510(k) K944290
K944290 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "CATHETERS, BILIARY CATHETERS, UROLOGICAL". The FDA issued a decision of Substantially Equivalent on December 8, 1994. The device falls under product code FFA (Tube, Drainage, Suprapubic), a Class II device regulated under 21 CFR 876.5090. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1994
- Date Received
- September 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Drainage, Suprapubic
- Device Class
- Class II
- Regulation Number
- 876.5090
- Review Panel
- GU
- Submission Type