Annuloflo System
FDA 510(k) K970375 · Carbomedics, Inc.
510(k) numberK970375
Submission
- Device name
- Annuloflo System
- Applicant
- Carbomedics, Inc.
Austin, TX, US - Received
- February 3, 1997
- Decision date
- July 25, 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
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 |
|---|---|---|
| K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration)DSY · Traditional | 02/19/1997ST |
| K962154 | Carbomedics HandleDTJ · Traditional | 08/27/1996SE |
| K960923 | Carbomedics Mitral RotatorMOP · Traditional | 04/29/1996SE |
| K960706 | Vascutek Vascusoft Plus Vascular GraftDSY · Traditional | 04/25/1996SESP |
| K960169 | Carbomedics Valve TesterDTJ · Traditional | 04/15/1996SE |
| K955588 | Vascutek Graft Sizer SetDSY · Traditional | 03/07/1996ST |
| K952184 | Carbomedics Supra-Annular Valve SizerDTI · Traditional | 11/29/1995SE |
| K951368 | Carbomedics Exended Mitral RotatorMOP · Traditional | 06/20/1995SE |
| K942736 | Carbomedics(R) Prosthetic Heart Valve Holder HandleDTJ · Traditional | 07/06/1994SE |
| K934951 | Valve SizerDTI · Traditional | 12/10/1993SE |
Questions and answers
When was Annuloflo System cleared by the FDA?
Annuloflo System (K970375) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on July 25, 1997, 172 days after the submission was received.
What is the product code of K970375?
The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.