Product code KRH— Cardiovascular
PUIG MASSANA-SHILEY ANNULOPLASTY RING
- Classification name
- Ring, Annuloplasty
- Device class
- Class 2
- Regulation
- 21 CFR 870.3800
- Advisory panel
- Cardiovascular
- Total cleared
- 75
- First cleared
- Most recent
Market context for product code KRH
FDA has cleared devices under product code KRH between 1979 and 2026, filed by 30 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2020
- 2019
- 2018
- 2016
- 2014
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
Top applicants under product code KRH
Adverse events under product code KRH
product code KRH- Death
- 45
- Injury
- 2,235
- Total
- 2,280
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KRH
- K261707 — MEMO 4D Curve Semirigid mitral annuloplasty ring
- K260498 — TriMemo SEMIRIGID ANNULOPLASTY RING
- K253232 — Seguin Annuloplasty Ring
- K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)
- K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)
- K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF)
- K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF)
- K230679 — WellsForm Tricuspid Annuloplasty Band (WF)
- K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring
- K202253 — TruForm Sievers Annuloplasty Ring
- K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
- K192762 — Physio Flex Annuloplasty Ring
- K190506 — NeoForm Annuloplasty Ring
- K181132 — Tri-Ad 2.0 Adams Tricuspid Band
- K180411 — MEMO 4D
- K161815 — FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
- K142221 — MEMO 3D ReChord
- K103520 — CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
- K103812 — MITRA-LIFT
- K101212 — MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
- K093903 — ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
- K092876 — SJM ATTUNE ANNULOPLASTY RING
- K092310 — SEGUIN ANNULOPLASTY RING
- K090428 — ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
- K083623 — CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
- K083191 — DETLOGIX ANNULOPLASTY RING, MODEL: 5100
- K083683 — ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
- K083470 — CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
- K083835 — ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
- K070488 — MICARDIA ANNULOPLASTY BAND DR
- K073324 — MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
- K072655 — ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
- K071327 — MEMO 3D SEMIRIGID ANNULOPLASTY RING
- K071281 — UNIRING - ANNULOPLASTY RING WITH SIZERS
- K071214 — ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
- K061127 — CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
- K052970 — SIMPLICI-T ANNULOPLASTY SYSTEM
- K052565 — ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
- K052899 — ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
- K052860 — CG FUTURE ANNULOPLASTY BAND
- K042734 — SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
- K033685 — NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
- K032810 — DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
- K032250 — GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
- K023940 — SHELHIGH BIORING
- K023185 — ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
- K022363 — SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
- K021051 — ANNULOFLO SYSTEM, MITRAL MODEL AR700
- K020864 — EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
- K014161 — SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
- K014037 — SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
- K011395 — MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
- K000119 — SJM TAILOR ANNULOPLASTY RING, MODEL TARN
- K992056 — ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
- K984435 — MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
- K980487 — CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM
- K980534 — DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
- K970375 — ANNULOFLO SYSTEM
- K961246 — SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
- K960356 — POSTERIOR ANNULOPLASTY BAND (MODEL 607)
- K926138 — CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
- K923367 — COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
- K905175 — PTI ANNULOPLASTY RING(STERILE)
- K914972 — CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
- K914602 — DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED
- K912554 — ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
- K902159 — BIFLEX(TM) ANNULOPLASTY RING
- K893678 — DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
- K831949 — PROSTHETIC RINGS #4400 MITRAL & 4500
- K821261 — PUIG MASSANA-SHILEY ANNULOPLASTY RING
- K801879 — PUIG MASSANA-SHILEY ANNULOPLASTY RING
- K800147 — FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.
- K792441 — CARPENTIER-EDWARDS FLEX. ANNULOPLASTY
- K792646 — AMP DIRECT VASCULAR MONITORING SYSTEM
- K790534 — MERSILENE SUTURES
Data sourced from openFDA. This site is unofficial and independent of the FDA.