510(k) K013866
K013866 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "CONVOY ADVANCED DELIVERY SHEATH KIT". The FDA issued a decision of Substantially Equivalent on December 14, 2001. The device falls under product code DBY (Fab, Rhodamine, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5520. Boston Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2001
- Date Received
- November 21, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fab, Rhodamine, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5520
- Review Panel
- IM
- Submission Type