510(k) K961507
K961507 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS". The FDA issued a decision of Substantially Equivalent - Subject to Tracking Reg. on Jul 10, 1996. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Boston Scientific Scimed, Inc. has 34 other 510(k) clearances on record.
Clearance details
- Decision
- ST (Substantially Equivalent - Subject to Tracking Reg.)
- Decision Date
- Jul 10, 1996
- Date Received
- Apr 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Tracheal, Expandable
- Device Class
- Class II
- Regulation Number
- 878.3720
- Review Panel
- AN
- Submission Type
- 510(k)