510(k) K911630
K911630 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON". The FDA issued a decision of Substantially Equivalent on Sep 27, 1991. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 27, 1991
- Date Received
- Apr 11, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stents, Drains And Dilators For The Biliary Ducts
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type
- 510(k)