Product code KRH
- Device name
- Ring, Annuloplasty
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3800
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260498 | TriMemo™ SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | 2026-04-14 |
| K253232 | Seguin Annuloplasty Ring | ABBOTT MEDICAL | 2025-10-29 |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | Edwards Lifesciences, LLC | 2025-09-23 |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences, LLC | 2025-09-17 |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2025-07-25 |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. | 2024-04-09 |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF) | Genesee Biomedical, Inc. | 2023-05-26 |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | Corcym S.r.l. | 2023-04-07 |
| K202253 | TruForm Sievers Annuloplasty Ring | Genesee Biomedical, Inc. | 2020-10-06 |
| K201449 | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring | Medtronic, Inc. | 2020-07-01 |
| K192762 | Physio Flex Annuloplasty Ring | Edwards Lifesciences, LLC | 2019-12-16 |
| K190506 | NeoForm Annuloplasty Ring | Genesee Biomedical, Inc. | 2019-04-18 |
| K181132 | Tri-Ad 2.0 Adams Tricuspid Band | Medtronic | 2018-05-29 |
| K180411 | MEMO 4D | Sorin Group Italia S.R.L. | 2018-03-16 |
| K161815 | FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band | Genesee Biomedical, Inc. | 2016-10-12 |
| K142221 | MEMO 3D ReChord | Sorin Group Italia S.R.L. | 2014-08-29 |
| K103520 | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | Edwards Lifesciences, LLC | 2011-06-24 |
| K103812 | MITRA-LIFT | Sciencity Co., Ltd. | 2011-05-18 |
| K101212 | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R | Medtronic, Inc. | 2010-08-07 |
| K093903 | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC | Genesee Biomedical, Inc. | 2010-07-15 |
| K092876 | SJM ATTUNE ANNULOPLASTY RING | St Jude Medical | 2009-10-16 |
| K092310 | SEGUIN ANNULOPLASTY RING | St Jude Medical | 2009-08-27 |
| K090428 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC | Genesee Biomedical, Inc. | 2009-05-07 |
| K083623 | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 | Edwards Lifesciences, LLC | 2009-04-15 |
| K083191 | DETLOGIX ANNULOPLASTY RING, MODEL: 5100 | Edwards Lifesciences, LLC | 2009-04-10 |
| K083683 | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC | Genesee Biomedical, Inc. | 2009-02-25 |
| K083470 | CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 | Edwards Lifesciences, LLC | 2009-01-23 |
| K083835 | ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR | St Jude Medical | 2009-01-23 |
| K070488 | MICARDIA ANNULOPLASTY BAND DR | Micardia Corporation | 2008-09-04 |
| K073324 | MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R | Medtronic, Inc. | 2008-03-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B0404200300 | NeoForm | GENESEE BIOMEDICAL, INC. | 2019-05-22 |
| B0404200320 | NeoForm | GENESEE BIOMEDICAL, INC. | 2019-05-22 |
| B0404200280 | NeoForm | GENESEE BIOMEDICAL, INC. | 2019-05-22 |
| B040FBN300 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBN400 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBN380 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBN360 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBN340 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBN280 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBN260 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBN240 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBH380 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBH360 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBH340 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBH320 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBH300 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBH280 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBH260 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBH240 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FBH400 | FlexForm Annuloplasty Band | GENESEE BIOMEDICAL, INC. | 2017-02-02 |
| B040FRN2600 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FRH400 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FRH380 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FRH360 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FRH340 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FRH320 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FRH300 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FRH280 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FRH260 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |
| B040FRH240 | FlexForm Annuloplasty Ring | GENESEE BIOMEDICAL, INC. | 2017-02-01 |