510(k) K883909
K883909 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "SURGICAL SPRING CLIPS". The FDA issued a decision of Substantially Equivalent on December 27, 1988. The device falls under product code DSS (Clip, Vascular), a Class II device regulated under 21 CFR 870.3250. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1988
- Date Received
- September 15, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Vascular
- Device Class
- Class II
- Regulation Number
- 870.3250
- Review Panel
- CV
- Submission Type