510(k) K865085
K865085 is an FDA 510(k) premarket notification submitted by Van-Tec, Inc. for the device "KAMINSKY COMBINATION STENT & INJECTION CATHETER". The FDA issued a decision of Substantially Equivalent on March 25, 1987. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Van-Tec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1987
- Date Received
- December 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.4620
- Review Panel
- GU
- Submission Type