KRH · Class II · 21 CFR 870.3800

FDA Product Code KRH: Ring, Annuloplasty

Annuloplasty rings restore mitral valve geometry and competence in mitral regurgitation surgery. FDA product code KRH covers annuloplasty rings used in heart valve repair.

These rigid or flexible rings are sewn to the mitral or tricuspid annulus to reduce annular diameter, restore the normal saddle-shaped geometry, and support the valve leaflets, enabling durable repair of regurgitant valves while preserving native valve tissue.

KRH devices are Class II medical devices, regulated under 21 CFR 870.3800 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Genesee Biomedical, Inc., Edwards Lifesciences, LLC and St. Jude Medical, Inc..

75
Total
73
Cleared
102d
Avg days
1979
Since
75 devices
49–72 of 75
Cleared Apr 17, 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Jan 15, 2002
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
K014161
St. Jude Medical, Inc.
Cardiovascular · 27d
Cleared Jan 04, 2002
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
K014037
St. Jude Medical, Inc.
Cardiovascular · 28d
Cleared Jul 12, 2001
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395
Medtronic Vascular
Cardiovascular · 66d
Cleared Feb 17, 2000
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
K000119
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared Oct 12, 1999
ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
K992056
Sulzer Carbomedics, Inc.
Cardiovascular · 116d
Cleared Jan 07, 1999
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435
Medtronic Vascular
Cardiovascular · 27d
Cleared Jul 07, 1998
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM
K980487
Baxter Edwards
Cardiovascular · 148d
Cleared Apr 30, 1998
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
K980534
The Heart Valve Div. Medtronic Cardiovascular Surg
Cardiovascular · 78d
Cleared Jul 25, 1997
ANNULOFLO SYSTEM
K970375
Carbomedics, Inc.
Cardiovascular · 172d
Cleared Feb 14, 1997
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
K961246
St. Jude Medical, Inc.
Cardiovascular · 319d
Cleared Aug 27, 1996
POSTERIOR ANNULOPLASTY BAND (MODEL 607)
K960356
The Heart Valve Div. Medtronic Cardiovascular Surg
Cardiovascular · 215d
Cleared Jun 22, 1993
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
K926138
Baxter Healthcare Corp
Cardiovascular · 197d
Cleared Jan 06, 1993
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367
Baxter Healthcare Corp
Cardiovascular · 181d
Cleared Feb 14, 1992
PTI ANNULOPLASTY RING(STERILE)
K905175
Pioneering Technologies, Inc.
Cardiovascular · 452d
Cleared Jan 09, 1992
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
K914972
Baxter Healthcare Corp
Cardiovascular · 64d
Cleared Nov 22, 1991
DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED
K914602
The Heart Valve Div. Medtronic Cardiovascular Surg
Cardiovascular · 38d
Cleared Sep 09, 1991
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
K912554
Baxter Healthcare Corp
Cardiovascular · 90d
Cleared Jan 18, 1991
BIFLEX(TM) ANNULOPLASTY RING
K902159
St. Jude Medical, Inc.
Cardiovascular · 248d
Cleared Nov 27, 1989
DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
K893678
Medtronic Blood Systems, Inc.
Cardiovascular · 195d
Not Cleared Jul 29, 1983
PROSTHETIC RINGS #4400 MITRAL & 4500
K831949
American Edwards Laboratories
Cardiovascular · 43d
Cleared Jun 16, 1982
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K821261
Shiley, Inc.
Cardiovascular · 44d
Cleared Dec 16, 1980
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K801879
Shiley, Inc.
Cardiovascular · 132d
Not Cleared Mar 17, 1980
CARPENTIER-EDWARDS FLEX. ANNULOPLASTY
K792441
Edwards Laboratories
Cardiovascular · 109d