510(k) K771425
K771425 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "A-V SHUNT EXTENSION". The FDA issued a decision of Substantially Equivalent on January 3, 1978. The device falls under product code FKN (Adaptor, Shunt), 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
- January 3, 1978
- Date Received
- August 1, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Shunt
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type