510(k) K000119
K000119 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "SJM TAILOR ANNULOPLASTY RING, MODEL TARN". The FDA issued a decision of Substantially Equivalent on February 17, 2000. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. St. Jude Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2000
- Date Received
- January 18, 2000
- Clearance Type
- Special
- 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