Panels › Cardiovascular › Product code KRH · Class 2
Ring, Annuloplasty
Regulation 870.3800
2510(k)s in 12 months (75 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KRH
| Company | 510(k)s | Recalls |
|---|---|---|
| Genesee Biomedical, Inc. | 13 | 0 |
| St Jude Medical | 10 | 0 |
| Edwards Lifesciences, LLC | 9 | 0 |
| Baxter Healthcare Corp | 4 | 0 |
| Medtronic | 4 | 0 |
| Corcym S.r.l. | 3 | 0 |
| The Heart Valve Div. Medtronic Cardiovascular Surg | 3 | 0 |
| Medtronic Heart Valves | 3 | 0 |
| Medtronic Vascular | 3 | 0 |
| Sulzer Carbomedics, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 4, 2002 | K014037 | SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) St. Jude Medical, Inc. | KRH |
| Jul 12, 2001 | K011395 | MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B Medtronic Vascular | KRH |
| Feb 17, 2000 | K000119 | SJM TAILOR ANNULOPLASTY RING, MODEL TARN St. Jude Medical, Inc. | KRH |
| Oct 12, 1999 | K992056 | ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 Sulzer Carbomedics, Inc. | KRH |
| Jan 7, 1999 | K984435 | MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M Medtronic Vascular | KRH |
| Jul 7, 1998 | K980487 | CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM Baxter Edwards | KRH |
| Apr 30, 1998 | K980534 | DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H The Heart Valve Div. Medtronic Cardiovascular Surg | KRH |
| Jul 25, 1997 | K970375 | ANNULOFLO SYSTEM Carbomedics, Inc. | KRH |
| Feb 14, 1997 | K961246 | SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M St. Jude Medical, Inc. | KRH |
| Aug 27, 1996 | K960356 | POSTERIOR ANNULOPLASTY BAND (MODEL 607) The Heart Valve Div. Medtronic Cardiovascular Surg | KRH |
| Jun 22, 1993 | K926138 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING Baxter Healthcare Corp | KRH |
| Jan 6, 1993 | K923367 | COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 Baxter Healthcare Corp | KRH |
| Feb 14, 1992 | K905175 | PTI ANNULOPLASTY RING(STERILE) Pioneering Technologies, Inc. | KRH |
| Jan 9, 1992 | K914972 | CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS Baxter Healthcare Corp | KRH |
| Nov 22, 1991 | K914602 | DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED The Heart Valve Div. Medtronic Cardiovascular Surg | KRH |
| Sep 9, 1991 | K912554 | ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI Baxter Healthcare Corp | KRH |
| Jan 18, 1991 | K902159 | BIFLEX(TM) ANNULOPLASTY RING St. Jude Medical, Inc. | KRH |
| Nov 27, 1989 | K893678 | DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H Medtronic Blood Systems, Inc. | KRH |
| Jul 29, 1983 | K831949 | PROSTHETIC RINGS #4400 MITRAL & 4500 American Edwards Laboratories | KRH |
| Jun 16, 1982 | K821261 | PUIG MASSANA-SHILEY ANNULOPLASTY RING Shiley, Inc. | KRH |
| Dec 16, 1980 | K801879 | PUIG MASSANA-SHILEY ANNULOPLASTY RING Shiley, Inc. | KRH |
| Apr 24, 1980 | K800147 | FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. Usifroid | KRH |
| Mar 17, 1980 | K792441 | CARPENTIER-EDWARDS FLEX. ANNULOPLASTY Edwards Laboratories | KRH |
| Feb 11, 1980 | K792646 | AMP DIRECT VASCULAR MONITORING SYSTEM American Medical Products, Inc. | KRH |
| Mar 26, 1979 | K790534 | MERSILENE SUTURES Hancock Laboratories, Inc. | KRH |
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