510(k) K942812
K942812 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "FLO-RESTER DISPOSABLE VESSEL OCCLUDER". The FDA issued a decision of Substantially Equivalent on August 1, 1994. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1994
- Date Received
- June 14, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type