Carpentier-Edwards Flex. Annuloplasty
FDA 510(k) K792441 · Edwards Laboratories
510(k) numberK792441
Submission
- Device name
- Carpentier-Edwards Flex. Annuloplasty
- Applicant
- Edwards Laboratories
Mchenry, IL, US - Received
- November 29, 1979
- Decision date
- March 17, 1980
- Decision
- Substantially Equivalent - Subject to Tracking & PMS (PT)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRH – Ring, Annuloplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3800
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261707 | MEMO 4D Curve Semirigid mitral annuloplasty ringKRH · Special | Corcym S.r.l. | 06/18/2026SE |
| K260498 | TriMemo SEMIRIGID ANNULOPLASTY RINGKRH · Abbreviated | Corcym S.r.l. | 04/14/2026SE |
| K253232 | Seguin Annuloplasty RingKRH · Special | Abbott Medical | 10/29/2025SE |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900)KRH · Abbreviated | Edwards Lifesciences, LLC | 09/23/2025SE |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH · Abbreviated | Edwards Lifesciences, LLC | 09/17/2025SE |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | Genesee Biomedical, Inc. | 07/25/2025SE |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | Genesee Biomedical, Inc. | 04/09/2024SE |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF)KRH · Traditional | Genesee Biomedical, Inc. | 05/26/2023SE |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…KRH · Traditional | Corcym S.r.l. | 04/07/2023SE |
| K202253 | TruForm Sievers Annuloplasty RingKRH · Traditional | Genesee Biomedical, Inc. | 10/06/2020SE |
More from Genesee Biomedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801552 | Mod. 9542 Flow-Thru Inject. Temp. SensorKRB · Traditional | 07/28/1980SE |
| K800655 | Model 100 SpectraviewDQC · Traditional | 04/16/1980SE |
| K792034 | Integral Disposable Holder CarpentierDTJ · Traditional | 12/07/1979SE |
| K790047 | Cardiac Output Computer, Mdel 9520ADXG · Traditional | 02/26/1979SE |
| K790022 | Disposable Holder for BioprosthesisDTJ · Traditional | 01/15/1979SE |
| K781535 | Ac Adapter:Models 9525,9526,9527DXG · Traditional | 09/15/1978SE |
| K771663 | Probe & CatheterKRB · Traditional | 09/20/1977SE |
| K771046 | Vena Cava Umbrella Filter, Model 7321DTK · Traditional | 06/22/1977SE |
| K760151 | Applicator,Angiography (7310MOBIN-UDDIN)DTK · Traditional | 08/26/1976SE |
| K760192 | Computer, Thermodilution Cardiac (9520)DXG · Traditional | 07/19/1976SE |
Questions and answers
When was Carpentier-Edwards Flex. Annuloplasty cleared by the FDA?
Carpentier-Edwards Flex. Annuloplasty (K792441) received a 510(k) decision of Substantially Equivalent - Subject to Tracking & PMS on March 17, 1980, 109 days after the submission was received.
What is the product code of K792441?
The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.