510(k) K923367
- Device
- COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K923367
- Product code
- KRH
- Decision
- Se - Postmarket Surveillance Required (SESP)
- Decision date
- 1993-01-06
- Date received
- 1992-07-09
- Regulation
- 870.3800
- Classification name
- Ring, Annuloplasty
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Roberta Hines
- Address
- P O Box 11150 Santa Ana CA US 92711 92711
FDA Registration Numbers#
- 1720929
- 3012179728
- 9617601
- 3007113487
- 3005687633
- 2031093
- 2025587
- 2029275
- 1723241
- 2015691
- 3008500478
- 3015287573
- 2648612
- 2135147
Source Documents#
Other 510(k) Records For Product Code KRH #
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases