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Data / Medical devices / Germany / Rhenus Se & Co. KG

Rhenus Se & Co. KG: FDA-registered device maker in Holzwickede North Rhine-Westphalia, Germany, 38 510(k) clearances and 4 PMA approvals

Rhenus Se & Co. KG is registered with the FDA (registration 3014656749) in Holzwickede North Rhine-Westphalia, Germany. It lists 45 device types. The FDA files 38 510(k) clearances and 4 PMA approvals under its listings, the newest dated April 4, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Rhenus Se & Co. KG
FDA registration number
3014656749
Address
Rhenus Platz 1, Holzwickede North Rhine-Westphalia, Germany, 59439
Owner or operator
Rhenus SE & Co. KG (10057982)
Roles
Exporter to the US
First device listed
June 22, 2018
Registered through
2026
Brand names listed
0.2 Micron In-Line Flat Anesthesia Conduction Filter;, 12 Fr. Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter, 14 Fr Two-Lumen Hemodialysis Catheterization Kit/Set;, ASTRON, Anesthesia Face mask, pediatric; Anesthesia Face mask with / without hook ring, black; Facemask Silicone, Arrow Arterial Catheterization Set;, Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter;, Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, NasopharyngealBTQ1Exporter to the USaccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Exporter to the USaccessdata.fda.gov
Anesthesia Conduction KitCAZ2Exporter to the USaccessdata.fda.gov
Bag, IntestineKGY1Exporter to the USaccessdata.fda.gov
Balloon, EpistaxisEMX1Exporter to the USaccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Exporter to the USaccessdata.fda.gov
Catheter, Angioplasty, Peripheral, TransluminalLIT2Exporter to the USaccessdata.fda.gov
Catheter, Conduction, AnestheticBSO2Exporter to the USaccessdata.fda.gov
Catheter, Flow DirectedDYG2Exporter to the USaccessdata.fda.gov
Catheter, Hemodialysis, Non-ImplantedMPB2Exporter to the USaccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Exporter to the USaccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Exporter to the USaccessdata.fda.gov
Catheter, PercutaneousDQY2Exporter to the USaccessdata.fda.gov
Catheter, RectalGBT2Exporter to the USaccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Exporter to the USaccessdata.fda.gov
Catheter, SubclavianLFJ2Exporter to the USaccessdata.fda.gov
Catheter, Suprapubic (And Accessories)KOB2Exporter to the USaccessdata.fda.gov
Catheter, UrethralGBM2Exporter to the USaccessdata.fda.gov
Catheter, UrologicalKOD2Exporter to the USaccessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX2Exporter to the USaccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Exporter to the USaccessdata.fda.gov
Connector, Airway (Extension)BZA1Exporter to the USaccessdata.fda.gov
Coronary Covered StentNIVfExporter to the USaccessdata.fda.gov
Coronary Drug-Eluting StentNIQ3Exporter to the USaccessdata.fda.gov
Device, RebreathingBYW1Exporter to the USaccessdata.fda.gov
Dilator, Vessel, For Percutaneous CatheterizationDRE2Exporter to the USaccessdata.fda.gov
Electrode, NeedleGXZ2Exporter to the USaccessdata.fda.gov
Gag, MouthKBN1Exporter to the USaccessdata.fda.gov
Introducer, CatheterDYB2Exporter to the USaccessdata.fda.gov
Laryngoscope, RigidCCW1Exporter to the USaccessdata.fda.gov
Lubricant, PatientKMJ1Exporter to the USaccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Exporter to the USaccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Exporter to the USaccessdata.fda.gov
Stent, CoronaryMAF3Exporter to the USaccessdata.fda.gov
Stent, IliacNIO3Exporter to the USaccessdata.fda.gov
Stent, Superficial Femoral ArteryNIP3Exporter to the USaccessdata.fda.gov
Stethoscope, EsophagealBZW1Exporter to the USaccessdata.fda.gov
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)FCM2Exporter to the USaccessdata.fda.gov
Tube Tracheostomy And Tube CuffJOH2Exporter to the USaccessdata.fda.gov
Tube, Bronchial (W/Wo Connector)BTS2Exporter to the USaccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Exporter to the USaccessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)CBI2Exporter to the USaccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Exporter to the USaccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Exporter to the USaccessdata.fda.gov
Wire, Guide, CatheterDQX2Exporter to the USaccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 4, 2025K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterLITSubstantially EquivalentBiotronik, Inc.accessdata.fda.gov
November 20, 2020K203179Fortress Introducer Sheath SystemDYBSubstantially EquivalentContract Medical International, GmbHaccessdata.fda.gov
October 4, 2016K161075Arrow Epidural Catheter KitCAZSubstantially EquivalentTeleflexmedical, Inc.accessdata.fda.gov
March 27, 2015K140110FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SETBSOSubstantially EquivalentTeleflex, Inc.accessdata.fda.gov
May 30, 2014K130304LMA FAMILY OF AIRWAYSCAESubstantially EquivalentThe Laryngeal Mask Co., Ltd.accessdata.fda.gov
December 21, 2012K122690ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLECAZSubstantially EquivalentArrow International, Inc.accessdata.fda.gov
September 28, 2012K121462EZ-BLOCKERCBISubstantially EquivalentEz-Blocker B.V.accessdata.fda.gov
December 20, 2011K113468ELM PTA BALLON DILATATION CATHETERLITSubstantially EquivalentCreagh Medical, Ltd.accessdata.fda.gov
December 18, 2009K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520DQYSubstantially EquivalentArrow Intl., Inc.accessdata.fda.gov
November 17, 2006K062523TRU-MR LARYNGOSCOPE SETCCWSubstantially EquivalentTruphatek International, Ltd.accessdata.fda.gov
July 16, 2002K014246AVID-NIT NERVE STIMULATION NEEDLESCAZSubstantially EquivalentAvid N.I.T., Inc.accessdata.fda.gov
February 26, 2002K010797RUSCH MILLER-ABBOTT TUBEKNTSubstantially EquivalentRusch Intl.accessdata.fda.gov
May 9, 2001K010420RUSCH MMG/O'NEIL CATHETERFCMSubstantially EquivalentRusch, Inc.accessdata.fda.gov
September 14, 2000K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPBSubstantially EquivalentArrow Intl., Inc.accessdata.fda.gov
February 4, 2000K991580ILM ENDOTRACHEAL TUBEBTRSubstantially EquivalentThe Laryngeal Mask Co., Ltd.accessdata.fda.gov
December 9, 1999K993063RUSCH BRILLANT SILICONE FOLEYEZLSubstantially EquivalentRusch Intl.accessdata.fda.gov
August 3, 1999K990619RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILEBTRSubstantially EquivalentRusch Intl.accessdata.fda.gov
May 26, 1999K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPBSubstantially EquivalentArrow Intl., Inc.accessdata.fda.gov
May 18, 1999K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPBSubstantially EquivalentArrow Intl., Inc.accessdata.fda.gov
June 5, 1998K981203RUSCH BLAKEMORE 3 LUMEN, STERILEKNTSubstantially EquivalentRusch Intl.accessdata.fda.gov
May 18, 1998K973892RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)KNTSubstantially EquivalentRusch Intl.accessdata.fda.gov
January 8, 1998K972184RUSCH BRILLANT SILICONE FOLEY CATHETEREZLSubstantially EquivalentRusch Intl.accessdata.fda.gov
October 10, 1997K964056RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILEJOHSubstantially EquivalentRusch Intl.accessdata.fda.gov
June 28, 1996K955564RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILEJOHSubstantially EquivalentRusch, Inc.accessdata.fda.gov
June 27, 1996K955495RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILEBTRSubstantially EquivalentRusch, Inc.accessdata.fda.gov
November 27, 1995K953963RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATIONBTSSubstantially EquivalentRusch, Inc.accessdata.fda.gov
July 25, 1995K952187RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILEKOBSubstantially EquivalentRusch, Inc.accessdata.fda.gov
May 23, 1995K935842RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYEBTRSubstantially EquivalentRusch, Inc.accessdata.fda.gov
December 21, 1994K944301HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380BTMSubstantially EquivalentHudson Respiratory Care, Inc.accessdata.fda.gov
June 22, 1993K931166RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EYBTRSubstantially EquivalentRusch, Inc.accessdata.fda.gov
July 26, 1991K904834INTAVENT LARYNGEAL MASKCAESubstantially EquivalentIntavent Intl. S.A.accessdata.fda.gov
July 24, 1990K900263ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZUnknownArrow Intl., Inc.accessdata.fda.gov
January 3, 1990K895417ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KITLFJSubstantially EquivalentArrow Intl., Inc.accessdata.fda.gov
November 6, 1989K895268ARROW HANDS-OFF THERMO-PACEDQOSubstantially EquivalentArrow Intl., Inc.accessdata.fda.gov
August 25, 1986K862056[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPDQYSubstantially EquivalentArrow Intl., Inc.accessdata.fda.gov
April 13, 1984K841036RECTAL BALLOON CATHETERSKNTSubstantially EquivalentInmed Corp.accessdata.fda.gov
January 30, 1984K833918INFUSION PORT BALLOON THERMODILUTIONDYGSubstantially EquivalentCritikon Company, LLCaccessdata.fda.gov
August 10, 1982K822082SHERIDAN/HVT,CF, UNCUFFEDBTRSubstantially EquivalentSheridan Catheter Corp.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 22, 2019P170030ORSIRO Sirolimus Eluting Coronary Stent SystemNIQ63September 24, 2026accessdata.fda.gov
March 23, 2017P160025ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEMNIP25September 11, 2026accessdata.fda.gov
February 14, 2017P160003PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEMMAF25June 5, 2026accessdata.fda.gov
December 17, 2015P140030ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEMNIO24September 11, 2026accessdata.fda.gov

Compare with other makers

Updated September 24, 2026. 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.