Data / Medical devices / Mexico / Bard Reynosa S.A. De C.V.
Bard Reynosa S.A. De C.V.: FDA-registered device maker in REYNOSA Tamaulipas, Mexico, 39 510(k) clearances
Bard Reynosa S.A. De C.V. is registered with the FDA (registration 9617592) in REYNOSA Tamaulipas, Mexico. It lists 48 device types. The FDA files 39 510(k) clearances under its listings, the newest dated May 13, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617592
- FEI number
- 3002468371
- Address
- BLVD. MONTEBELLO No. 1 PARQUE INDUSTRIAL COLONIAL, REYNOSA Tamaulipas, Mexico, --
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- March 18, 1994
- Registered through
- 2026
- Brand names listed
- Accessory - Foam Strips, AccuCath Ace Intravascular Catheter, Advance Introducer and SecureLoc Safety Introducer, Align Introducers, AllPoints Dressing Change Kit, Alphacurve, Atlas Gold PTA Dilatation Catheter, Atlas PTA Balloon Dilatation Catheter 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 13, 2022 | K213203 | Provena(TM) Midline Catheter | PND | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 8, 2017 | K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | PTI | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 1, 2015 | K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | NIE | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| February 20, 2015 | K143135 | Spring Coil Guidewire | DQX | Substantially Equivalent | Neometrics, Inc. | accessdata.fda.gov |
| September 24, 2014 | K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER | NIE | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| August 21, 2012 | K121485 | GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING | QSY | Substantially Equivalent | Hemcon Medical Technologies Europe, Ltd. | accessdata.fda.gov |
| July 21, 2011 | K102405 | INFUSION SET FOR POWERPICC SOLO 2 CATHETER | FPA | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 17, 2010 | K102159 | POWERPICC SV CATHETERS | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 7, 2009 | K091324 | SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 12, 2009 | K090102 | NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS | MPB | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| October 31, 2007 | K072130 | PTFE PEEL AWAY MICROINTRODUCER | DYB | Substantially Equivalent | Intromed | accessdata.fda.gov |
| October 5, 2007 | K072230 | POWERPICC SOLO | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 8, 2007 | K070996 | 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 4, 2007 | K063848 | POWERGROSHONG PICC CATHETER | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 21, 2006 | K063240 | SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 14, 2006 | K060341 | SHERLOCK TIP LOCATION SYSTEM (TLS) | FOZ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 13, 2006 | K053501 | POWERPICC | LJS | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| November 23, 2005 | K051672 | POWERPICC | LJS | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| October 20, 2005 | K051991 | POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 15, 2005 | K050931 | 6 FR DL POWERPICC CATHETER | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 12, 2005 | K050600 | MINILOC SAFETY INFUSION SET | FPA | Substantially Equivalent | Specialized Health Products, Intl. | accessdata.fda.gov |
| February 18, 2005 | K050023 | SECURELOC; ADVANCINTRODUCER | DYB | Substantially Equivalent | Specialized Health Products, Inc. | accessdata.fda.gov |
| October 19, 2004 | K042445 | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT | ITX | Substantially Equivalent | Bard Access Systems, Inc. | accessdata.fda.gov |
| March 19, 2004 | K033389 | POWERPICC CATHETERS, MODELS 3175155, 3175135 | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 21, 2004 | K034020 | GROSHONG NXT PICC CATHETERS | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 21, 2004 | K034019 | POLY PER-Q-CATH PICC CATHETERS | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 30, 2003 | K030268 | NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS | MPB | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 18, 2002 | K023374 | GROSHONG NXT DUAL LUMEN PICC CATHETERS | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 13, 2001 | K010778 | NIAGARA SLIM-CATH | MPB | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 19, 2000 | K001901 | POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135 | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 27, 2000 | K993848 | MILLENNIUM HUBER PLUS SAFETY INFUSION SET | FPA | Substantially Equivalent | Millennium Medical Distribution, Inc. | accessdata.fda.gov |
| December 15, 1995 | K954422 | PER-Q-CATH MID-LINE | LJS | Substantially Equivalent | Gesco Intl., Inc. | accessdata.fda.gov |
| November 21, 1995 | K954104 | PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES | LJS | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 7, 1994 | K926331 | 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH | LJS | Unknown | Bard Access Systems, Inc. | accessdata.fda.gov |
| January 27, 1992 | K915167 | GESCO PER-Q-CATH CATHETER INTRODUCER | DYB | Substantially Equivalent | Gesco Intl., Inc. | accessdata.fda.gov |
| March 29, 1991 | K910622 | GESCO PER-Q-CATH REPAIR KIT | LJS | Unknown | Gesco Intl., Inc. | accessdata.fda.gov |
| October 22, 1990 | K903530 | PERCUTANEOUS INTRODUCERS | DYB | Substantially Equivalent | Davol, Inc. | accessdata.fda.gov |
| August 12, 1987 | K871080 | PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | DQY | Substantially Equivalent | Catheter Technology Corp. | accessdata.fda.gov |
| December 18, 1986 | K863606 | BUTTERFLY NON-CORING NEEDLE SET | FMI | Substantially Equivalent | Cormed, Inc., Sub. C.R.Bard, Inc. | accessdata.fda.gov |
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Updated May 13, 2022. 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.