Cosgrove Edwards Annuloplasty System, Model 4600
FDA 510(k) K923367 · Baxter Healthcare Corp
510(k) numberK923367
Submission
- Device name
- Cosgrove Edwards Annuloplasty System, Model 4600
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- July 9, 1992
- Decision date
- January 6, 1993
- Decision
- Unknown (SESP)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRH – Ring, Annuloplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3800
- Specialty
- Cardiovascular
- Implant
- Yes
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| K253232 | Seguin Annuloplasty RingKRH · Special | Abbott Medical | 10/29/2025SE |
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| 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 |
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Questions and answers
When was Cosgrove Edwards Annuloplasty System, Model 4600 cleared by the FDA?
Cosgrove Edwards Annuloplasty System, Model 4600 (K923367) received a 510(k) decision of Unknown on January 6, 1993, 181 days after the submission was received.
What is the product code of K923367?
The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.