510(k) K905159
K905159 is an FDA 510(k) premarket notification submitted by Bio-Vascular, Inc. for the device "FLO-RESTER(R) VESSEL SIZER". The FDA issued a decision of Substantially Equivalent on February 7, 1991. The device falls under product code DWP (Dilator, Vessel, Surgical), a Class II device regulated under 21 CFR 870.4475. Bio-Vascular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1991
- Date Received
- November 16, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, Surgical
- Device Class
- Class II
- Regulation Number
- 870.4475
- Review Panel
- CV
- Submission Type