510(k) K915129
K915129 is an FDA 510(k) premarket notification submitted by Utah Pioneer Medical, Inc. for the device "CATHETER WITH INTRODUCER AND SYRINGES". The FDA issued a decision of Substantially Equivalent (kit) on April 8, 1992. 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. Utah Pioneer Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- April 8, 1992
- Date Received
- November 13, 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