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 |
|---|---|---|---|
| Jun 19, 2001 | K011858 | INTERLINK THREADED LOCK CANNULA Bd | FPA |
| Jun 19, 2001 | K011187 | SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS Sterling Medivations, Inc. | FPA |
| Jun 12, 2001 | K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK Churchill Medical Systems, Inc. | FPA |
| Jun 12, 2001 | K011193 | NAC PLUS NEEDLELESS ACCESS CONNECTOR Porex Medical Products | FPA |
| Jun 7, 2001 | K011071 | PARADIGM QUICK-SET INFUSION SET Maersk Medical A/S | FPA |
| Jun 5, 2001 | K011580 | SIMPLICITY SOFT QD SILVER INFUSION SET Sterling Medivations, Inc. | FPA |
| May 29, 2001 | K010279 | MEDISYSTEMS LUER ACCESS INJECTION SITE Medisystems Corp. | FPA |
| May 14, 2001 | K010197 | EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET Exelint International, Co. | FPA |
| May 8, 2001 | K011120 | GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES Nipro Diabetes Systems, Inc. | FPA |
| Apr 30, 2001 | K010886 | SIMPLICITY WING INFUSION SET Sterling Medivations, Inc. | FPA |
| Apr 20, 2001 | K011003 | SAFESTING AND SAFESTING HUB Diasol, Inc. | FPA |
| Apr 20, 2001 | K010788 | SIMPLICITY SOFT QD EASY INFUSION SET Sterling Medivations, Inc. | FPA |
| Apr 18, 2001 | K010676 | SIMPLICITY WINGED QD INFUSION SET Sterling Medivations, Inc. | FPA |
| Apr 13, 2001 | K010647 | SIMPLICITY INFUSER INFUSION SET Sterling Medivations, Inc. | FPA |
| Apr 12, 2001 | K010846 | SIMPLICITY SILVER SET SOFT INFUSION Sterling Medivations, Inc. | FPA |
| Apr 12, 2001 | K000592 | UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET Myco Medical Supplies, Inc. | FPA |
| Mar 30, 2001 | K010538 | PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E Rd Medical Mfg., Inc. | FPA |
| Mar 15, 2001 | K010103 | SURSHIELD WINGED INFUSION SET Terumo Medical Corp. | FPA |
| Mar 13, 2001 | K010373 | SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103) Sterling Medivations, Inc. | FPA |
| Mar 6, 2001 | K002689 | SWABSITE SWABBABLE VALVE, MODEL 245000 Quest Medical, Inc. | FPA |
| Feb 15, 2001 | K003977 | DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET Disetronic Medical Systems AG | FPA |
| Feb 14, 2001 | K001329 | INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET Lifemed of California | FPA |
| Feb 5, 2001 | K003854 | INTRAVASCULAR ADMINISTRATION SET Infusion Devices, Inc. | FPA |
| Jan 11, 2001 | K003513 | TAXOL ADMINISTRATION SET Icu Medical, Inc. | FPA |
| Dec 22, 2000 | K002449 | BIOTEQ I.V. (INTRAVENOUS) SET Bioteque Corp. | FPA |
| Dec 13, 2000 | K003283 | SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103) Sterling Medivations, Inc. | FPA |
| Dec 13, 2000 | K001233 | ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S R-Group Intl. | FPA |
| Oct 24, 2000 | K002492 | SIMPLICITY SOFT INFUSION SET Sterling Medivations, Inc. | FPA |
| Oct 19, 2000 | K003225 | SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE Baxter Healthcare Corp | FPA |
| Oct 19, 2000 | K002471 | JETCAN HUBER NEEEDLE SET Pfm Produkte Fur Die Medizin AG | FPA |
| Sep 18, 2000 | K001599 | ACTI-FLEX IV ADMINISTRATION SET R-Group Intl. | FPA |
| Sep 7, 2000 | K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 Codan US Corp. | FPA |
| Aug 29, 2000 | K002138 | PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 Maersk Medical A/S | FPA |
| Aug 18, 2000 | K001832 | PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 Minimed, Inc. | FPA |
| Aug 18, 2000 | K001827 | PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 Minimed, Inc. | FPA |
| Aug 16, 2000 | K001106 | MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 Creative Plastic Technology | FPA |
| Aug 10, 2000 | K002006 | LIFESHIELD ADDITIVE PIERCING PIN Abbott Laboratories | FPA |
| Jul 21, 2000 | K001426 | KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER Kawasumi Laboratories America, Inc. | FPA |
| Jul 21, 2000 | K001424 | KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD Kawasumi Laboratories America, Inc. | FPA |
| Jul 21, 2000 | K001423 | KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY Kawasumi Laboratories America, Inc. | FPA |
| May 31, 2000 | K990331 | SURGEN VALVE Tiva Medical | FPA |
| May 10, 2000 | K000472 | POSI-LINK Icu Medical, Inc. | FPA |
| Apr 27, 2000 | K000942 | CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 Sims Deltec, Inc. | FPA |
| Apr 20, 2000 | K001102 | PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E Rd Medical Mfg., Inc. | FPA |
| Mar 3, 2000 | K994429 | VENUSA, LTD. EXTENSION SET WITH FILTER Venusa , Ltd. | FPA |
| Mar 1, 2000 | K000343 | NAC Y-ADP The Kipp Group | FPA |
| Feb 29, 2000 | K000152 | KIPPMED I.V. MANIFOLD The Kipp Group | FPA |
| Feb 23, 2000 | K992290 | EXEL INJECTION PLUG WITH CAP Exel Intl. | FPA |
| Feb 10, 2000 | K000017 | PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400 Rd Medical Mfg., Inc. | FPA |
| Jan 27, 2000 | K993848 | MILLENNIUM HUBER PLUS SAFETY INFUSION SET Millennium Medical Distribution, Inc. | FPA |
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