510(k) K992941
K992941 is an FDA 510(k) premarket notification submitted by Vascutech, Inc. for the device "LEMAITRE BILIARY CATHETER". The FDA issued a decision of Substantially Equivalent on January 12, 2000. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Vascutech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2000
- Date Received
- August 31, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Biliary
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type