Panels › General Hospital › Product code FPA · Class 2
Set, Administration, Intravascular
Regulation 880.5440
6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 7, 1995 | K953231 | PPMI-(XXX) AND PPMO-(XXX) Patriot Products, Inc. | FPA |
| Sep 1, 1995 | K950895 | HARMAC EXTENSION INFUSION SET Harmac Medical Products, Inc. | FPA |
| Aug 24, 1995 | K950153 | VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES Imed Corp. | FPA |
| Aug 18, 1995 | K952760 | FIXED FLOW RATE GRAVITY ADMINISTRATION SETS I-Flow Corp. | FPA |
| Aug 7, 1995 | K952664 | SOLUTION ADMINISTRATION SET Distronic Sterile Products, Inc. | FPA |
| Aug 7, 1995 | K952392 | MLI SET Medical Technologies of Georgia | FPA |
| Jul 27, 1995 | K952074 | SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER Baxter Healthcare Corp | FPA |
| Jul 26, 1995 | K950597 | CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE Distronic Sterile Products, Inc. | FPA |
| Jul 19, 1995 | K951922 | ADMINISTRATION SETS WITH BALL FLOAT Imed Corp. | FPA |
| Jul 14, 1995 | K942988 | FILTERED EXTENSION SETS B. Braun of America, Inc. | FPA |
| Jul 12, 1995 | K942271 | LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE Level 1 Technologies, Inc. | FPA |
| Jun 28, 1995 | K943591 | VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM Infusion Technology Intl. | FPA |
| Jun 14, 1995 | K945298 | SMARTFLOW I ADMINISTRATION SET River Medical, Inc. | FPA |
| May 31, 1995 | K952053 | E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS Becton Dickinson Vascular Access, Inc. | FPA |
| May 2, 1995 | K944692 | C-SERIES HOMEPUMP Block Medical, Inc. | FPA |
| Apr 10, 1995 | K943770 | LOW VOLUME MULTIPORT B. Braun of America, Inc. | FPA |
| Apr 10, 1995 | K943038 | STATLOCK-IPIDURAL Venetec, Inc. | FPA |
| Mar 29, 1995 | K944824 | SUREWING Gainor Medical U.S.A., Inc. | FPA |
| Mar 28, 1995 | K942931 | STATLOCK SECUREMENT DEVICES Venetec, Inc. | FPA |
| Mar 23, 1995 | K944293 | SABRATEK SABSIL SETS Sabratek Corp. | FPA |
| Mar 14, 1995 | K950304 | DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER Becton Dickinson Vascular Access, Inc. | FPA |
| Mar 14, 1995 | K950303 | DESERET(R) I.V. LOOP AND DESERET (R) J LOOP Becton Dickinson Vascular Access, Inc. | FPA |
| Mar 13, 1995 | K950302 | E-Z SET(R) AND MINICATH(R) INFUSION SETS Becton Dickinson Vascular Access, Inc. | FPA |
| Mar 13, 1995 | K946082 | BEECH PRO LOK FIXED Beech Medical Products, Inc. | FPA |
| Mar 3, 1995 | K933848 | PRESPO 7, SELF-SUFFICIENT DRIP DEVICE Bonding Corp. | FPA |
| Feb 17, 1995 | K942446 | I.V. ROLLER GUARD CLAMP Plastic Manufacturing and Marketing Group, Inc. | FPA |
| Feb 14, 1995 | K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET Imed Corp. | FPA |
| Feb 13, 1995 | K945617 | PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS Pharma-Plast Intl. A/S, DK | FPA |
| Feb 10, 1995 | K943897 | NU-SITE Medex, Inc. | FPA |
| Feb 8, 1995 | K942349 | MICROBORE EXTENSION SET Excelsior Medical Corp. | FPA |
| Feb 3, 1995 | K940657 | IV BAG PUMP I-Flow Corp. | FPA |
| Jan 31, 1995 | K941190 | CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET Icu Medical, Inc. | FPA |
| Jan 26, 1995 | K944619 | I.V.I.D. FLUID ADMINISTRATION SET MARKER Advanced Bioresearch Assoc. | FPA |
| Jan 20, 1995 | K935811 | BOLUS DISPENSER I-Flow Corp. | FPA |
| Jan 13, 1995 | K945070 | VERSASAE PLASTIC CANNULA- 11 GAUGE Imed Corp. | FPA |
| Dec 13, 1994 | K944208 | IV ADMINISTRATION SET FPA Medex, Inc. | FPA |
| Nov 29, 1994 | K941244 | SAFELINE SYSTEM TURN LOCK CANNULA Mcgaw, Inc. | FPA |
| Nov 10, 1994 | K940319 | R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE R-Group Intl. | FPA |
| Oct 4, 1994 | K942046 | PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE Pharmacia Deltec, Inc. | FPA |
| Aug 30, 1994 | K940697 | BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK Bd Becton Dickinson Vacutainer Systems Preanalytic | FPA |
| Aug 16, 1994 | K941453 | CHECK VALVE SOLUTION SET Douglas Medical Products Corp. | FPA |
| Aug 15, 1994 | K924010 | REDINOV PERFUSION SET Bipress, Inc. | FPA |
| Aug 10, 1994 | K934095 | IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS Y | FPA |
| Jul 29, 1994 | K934513 | PROVIDER PUMP SET W/INFUSION CARTRIDGE Abbott Laboratories | FPA |
| Jul 14, 1994 | K942181 | SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 Medtronic Minimed | FPA |
| Jun 29, 1994 | K941445 | EXTENSION SET WITH ANTI-SIPHON VALVE Pharmacia Deltec, Inc. | FPA |
| Jun 22, 1994 | K940897 | IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET Y | FPA |
| Jun 9, 1994 | K934119 | ENERGIZED DRUG CONTAINER SYSTEM Abbott Laboratories | FPA |
| May 9, 1994 | K925733 | ISOFLUX IXL FLOW REGULATOR Ferguson Medical | FPA |
| May 9, 1994 | K925732 | ISOFLUX IXZ FLOW REGULATOR Ferguson Medical | FPA |
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