510(k) K022067
K022067 is an FDA 510(k) premarket notification submitted by Boston Scientific for the device "CONVOY ADVANCED DELIVERY SHEATH". The FDA issued a decision of Substantially Equivalent on September 11, 2002. 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
- September 11, 2002
- Date Received
- June 25, 2002
- Clearance Type
- Traditional
- 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