510(k) K970375
K970375 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "ANNULOFLO SYSTEM". The FDA issued a decision of ST on July 25, 1997. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Carbomedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- July 25, 1997
- Date Received
- February 3, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ring, Annuloplasty
- Device Class
- Class II
- Regulation Number
- 870.3800
- Review Panel
- CV
- Submission Type