Data / Medical devices / Czechia / Arrow International C.R. a.s.
Arrow International C.R. a.s.: FDA-registered device maker in ZDAR NAD SAZAVOU Vysocina, Czechia, 105 510(k) clearances
Arrow International C.R. a.s. is registered with the FDA (registration 3006425876) in ZDAR NAD SAZAVOU Vysocina, Czechia. It lists 50 device types. The FDA files 105 510(k) clearances under its listings, the newest dated February 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006425876
- Address
- Jamska 2359/47, ZDAR NAD SAZAVOU Vysocina, Czechia, 591 01
- Owner or operator
- Arrow International LLC (subsidiary of Teleflex Incorporated (2518433)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- February 2, 1995
- Registered through
- 2026
- Brand names listed
- 14 Fr 2-L Hemodialysis Catheters, 2- Lumen PICC Products w/ Blue Flex, 2-Lumen Central Venous Access (MAC), 3-WAY STOPCOCK, 3M Tegaderm +Pad Film Dressing with Non-Adherent Pad Sterile, ACCESS KIT, ACCESS TRAY, AGB+ Multi-Lumen CVC Kit and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 105.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2023 | K222341 | Arrow 0.2 Micron Flat Filter, GVS | CAZ | Substantially Equivalent | Arrow International, LLC | accessdata.fda.gov |
| June 23, 2017 | K171146 | Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. | DQY | Substantially Equivalent | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | accessdata.fda.gov |
| March 17, 2017 | K162522 | UltraCath Continuous Nerve block Catheter | BSO | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| October 4, 2016 | K161075 | Arrow Epidural Catheter Kit | CAZ | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| June 21, 2016 | K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| May 27, 2016 | K161170 | BD Eclipse Hypodermic Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 27, 2015 | K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET | BSO | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| January 14, 2015 | K142553 | UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle | BSP | Substantially Equivalent | Unisis Corp. | accessdata.fda.gov |
| June 12, 2014 | K133280 | TERUMO SURFLO I.V. CATHETER | FOZ | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| April 26, 2013 | K130876 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| January 4, 2013 | K122854 | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER | DYB | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| September 28, 2012 | K121462 | EZ-BLOCKER | CBI | Substantially Equivalent | Ez-Blocker B.V. | accessdata.fda.gov |
| August 28, 2012 | K122027 | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 21, 2012 | K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 20, 2012 | K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| May 16, 2012 | K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | CAZ | Substantially Equivalent | Teleflex, Inc. | accessdata.fda.gov |
| May 10, 2012 | K112896 | ARRW EVOLUTION | LJS | Substantially Equivalent | Arrow International (Subsidiary of Teleflex Inc.) | accessdata.fda.gov |
| October 4, 2010 | K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| September 3, 2010 | K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL | FYA | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
| December 18, 2009 | K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| December 9, 2008 | K082297 | BUSSE SURGICAL DRAPE | KKX | Substantially Equivalent | Busse Hospital Disposables, Inc. | accessdata.fda.gov |
| November 28, 2008 | K082674 | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE | FMF | Substantially Equivalent | Spectra Medical Devices, Inc. | accessdata.fda.gov |
| June 27, 2008 | K080604 | PRESSURE INJFECTABLE PICC | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| June 9, 2008 | K080684 | WG-SURGICAL SUTURES WITH NEEDLE | GAP | Substantially Equivalent | Foosin Medical Supplies, Inc. | accessdata.fda.gov |
| February 26, 2008 | K080144 | MANDREL GUIDEWIRES OR M-WIRES | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| November 8, 2007 | K072247 | STERICAN HYPODERMIC NEEDLES | FMI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 10, 2007 | K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | KKX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 30, 2007 | K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| August 16, 2007 | K071459 | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 17, 2007 | K071111 | NON-ABSORBABLE SILK SUTURE | GAP | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 15, 2007 | K070150 | VASCUPUNCTURE PICC GUIDEWIRE | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| November 17, 2006 | K063280 | INJEKT SYRINGE | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 24, 2006 | K061289 | ARROW PRESSURE INJECTABLE PICC | LJS | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| September 7, 2004 | K040965 | PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES | BSP | Substantially Equivalent | Pajunk GmbH | accessdata.fda.gov |
| August 27, 2004 | K042126 | PICC | LJS | Unknown | Arrow Intl., Inc. | accessdata.fda.gov |
| July 12, 2004 | K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP | FMI | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| April 23, 2003 | K030937 | STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK | CAZ | Substantially Equivalent | Arrow International, Inc. | accessdata.fda.gov |
| October 18, 2002 | K022895 | ELCAM STOPCOCKS AND MANIFOLDS | FMG | Substantially Equivalent | Medical Device Consultants, Inc. | accessdata.fda.gov |
| July 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET | FMI | Substantially Equivalent | Bd | accessdata.fda.gov |
| June 19, 2002 | K021567 | STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| May 2, 2002 | K021120 | RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| October 31, 2001 | K011761 | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| May 10, 2001 | K011084 | MANDREL GUIDEWIRE ASSEMBLY | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| March 21, 2001 | K002507 | TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| March 1, 2001 | K010188 | BD ECLIPSE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Bd Medical Systems | accessdata.fda.gov |
| October 27, 2000 | K003006 | TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION | LJT | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| September 14, 2000 | K993933 | 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO | MPB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 29, 2000 | K001731 | AVID-NIT LOSS OF RESISTANCE SYRINGE | FMF | Substantially Equivalent | Avid Medical, Inc. | accessdata.fda.gov |
| July 12, 2000 | K001587 | 19 GA PLASTIC REINFORCED EPIDURAL CATHETER | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| June 16, 2000 | K000313 | TEARAWAY INTRODUCER SHEATH | DYB | Substantially Equivalent | Xentek Medical, Inc. | accessdata.fda.gov |
| March 8, 2000 | K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 23, 1999 | K991559 | MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD | FXX | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| May 26, 1999 | K991431 | 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT | MPB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| May 18, 1999 | K984022 | PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT | MPB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 13, 1998 | K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS | FMG | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| October 17, 1997 | K970864 | ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS | FOZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 21, 1997 | K962577 | ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| March 4, 1997 | K963257 | PERIPHERALLY INSERTED MEDLINE CATHETER | LJS | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 25, 1997 | K964142 | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS | KKX | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| April 18, 1995 | K950301 | ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, Inc. | accessdata.fda.gov |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| January 9, 1995 | K942045 | INSYTE INTRODUCER CATHETER | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, Inc. | accessdata.fda.gov |
| December 7, 1994 | K944355 | NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES | FMF | Substantially Equivalent | Nissho Corp. | accessdata.fda.gov |
| November 30, 1994 | K940079 | ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| March 31, 1994 | K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| March 28, 1994 | K930129 | ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | Unknown | Arrow Intl., Inc. | accessdata.fda.gov |
| January 7, 1994 | K930826 | SUTURE NONABSORBABLE - SILK | GAP | Substantially Equivalent | Surgical Specialties, Inc. | accessdata.fda.gov |
| December 16, 1993 | K931202 | STERILIZATION WRAP-STERISHEET | FRG | Substantially Equivalent | Arjo Wiggins Medical, Inc. | accessdata.fda.gov |
| September 22, 1993 | K931644 | GERTIE MARX NEEDLE | BSP | Substantially Equivalent | Intl. Medical-Dental Products USA, Inc. | accessdata.fda.gov |
| August 15, 1993 | K924385 | NEW HYDROPHILIC COATING FOR WIRE GUIDES | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| June 18, 1993 | K925126 | INTERLINK(TM) INJECTION SITE | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 13, 1993 | K923653 | NEEDLELESS INJECTION CANNULA | LJS | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| April 22, 1993 | K924607 | ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET | DYB | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| February 27, 1992 | K914531 | STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| October 21, 1991 | K911260 | ATRAUMATIC STANDARD SPROTTE NEEDLE | BSP | Substantially Equivalent | Pajunk GmbH | accessdata.fda.gov |
| October 25, 1990 | K903029 | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE | GAR | Substantially Equivalent | Look, Inc. | accessdata.fda.gov |
| July 24, 1990 | K900263 | ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER | FOZ | Unknown | Arrow Intl., Inc. | accessdata.fda.gov |
| January 3, 1990 | K895417 | ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT | LFJ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| November 6, 1989 | K895268 | ARROW HANDS-OFF THERMO-PACE | DQO | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| March 14, 1989 | K884552 | CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| January 17, 1989 | K884490 | INTRODUCER SAFETY SYRINGE | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 25, 1986 | K862056 | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| August 7, 1986 | K862801 | SPUNGUARD PLUS SURGICAL DRAPE | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| March 15, 1986 | K850960 | NON-ABSORBENT DRAPES & ABSORBENT TOWELS | KKX | Substantially Equivalent | Excel Health Care Products | accessdata.fda.gov |
| December 19, 1985 | K854816 | EPIDURAL ANESTHESIA NEEDLES | BSP | Substantially Equivalent | Reganes, Inc. | accessdata.fda.gov |
| February 21, 1985 | K850199 | POLY-LINED TOWEL/DRAPE LINE | KKX | Substantially Equivalent | Excel Health Care Products | accessdata.fda.gov |
| September 20, 1984 | K843263 | ARROW-JOHANS ECG ADAPTOR | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| January 30, 1984 | K833918 | INFUSION PORT BALLOON THERMODILUTION | DYG | Substantially Equivalent | Critikon Company, LLC | accessdata.fda.gov |
| January 30, 1984 | K833572 | HEPARIN-COATED BALLOON THERMODILUT | DYG | Substantially Equivalent | Critikon Company, LLC | accessdata.fda.gov |
| April 14, 1982 | K820648 | ARROW M.I.S. MULTI-LUMEN CATHETERIZA | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| January 22, 1982 | K820009 | ARROW JUGULAR PUNCTURE KIT 16 GA. | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| April 29, 1981 | K810962 | ARROW VESSEL CATHETER. KIT W/20GA INDWEL | DQY | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| March 27, 1981 | K810675 | ARROW RADIAL ARTERY CATHETERIZATION SET | DQX | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| September 16, 1980 | K801912 | ARROW POSITIVE PLACEMENT CON/EPIDURAL AN | CAZ | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
| June 20, 1980 | K801343 | B-D FILTER NEEDLE | FPB | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| February 13, 1980 | K800123 | DEXTEX II STERILIZATION WRAP | FRG | Substantially Equivalent | Ahlstrom Dexter | accessdata.fda.gov |
| February 22, 1979 | K782168 | 3-WAY STOPCOCK | FMG | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| January 23, 1979 | K782095 | STOPCOCKS, MANIFOLDS | DTL | Substantially Equivalent | Namic | accessdata.fda.gov |
| December 12, 1978 | K781978 | PUNCTURE KIT, DISPOSALBE VEIN | FMF | Substantially Equivalent | Arrow Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Infusion Line
- All makers of Anesthesia Conduction Kit
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Mask, Surgical
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
Updated February 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.