SJM Seguin Annuloplasty Ring Model Sar-M
FDA 510(k) K961246 · St. Jude Medical, Inc.
510(k) numberK961246
Submission
- Device name
- SJM Seguin Annuloplasty Ring Model Sar-M
- Applicant
- St. Jude Medical, Inc.
St. Paul, MN, US - Received
- April 1, 1996
- Decision date
- February 14, 1997
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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
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| K253232 | Seguin Annuloplasty RingKRH · Special | Abbott Medical | 10/29/2025SE |
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| 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 SJM Seguin Annuloplasty Ring Model Sar-M cleared by the FDA?
SJM Seguin Annuloplasty Ring Model Sar-M (K961246) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on February 14, 1997, 319 days after the submission was received.
What is the product code of K961246?
The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.