510(k) K810257
K810257 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "VESSEL TIPS, SIZES 13-18". The FDA issued a decision of Substantially Equivalent on March 13, 1981. The device falls under product code FKW (Tip, Vessel), a Class II device regulated under 21 CFR 876.5540. Quinton, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1981
- Date Received
- January 30, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tip, Vessel
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type