510(k) K910917
K910917 is an FDA 510(k) premarket notification submitted by Cathlab Corp. for the device "CATHLAB SILICONE BILIARY BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on August 2, 1991. The device falls under product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection), a Class II device regulated under 21 CFR 876.5010. Cathlab Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1991
- Date Received
- March 5, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type