510(k) K963750
K963750 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "RETRIEVAL SNARE". The FDA issued a decision of Substantially Equivalent on November 22, 1996. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1996
- Date Received
- September 18, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Flexible
- Device Class
- Class II
- Regulation Number
- 876.4680
- Review Panel
- GU
- Submission Type