The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Tri-ex Extraction Balloon With Multiple Sizing.
| Device ID | K040129 |
| 510k Number | K040129 |
| Device Name: | TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Marge Walls-walker |
| Correspondent | Marge Walls-walker WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-21 |
| Decision Date | 2004-02-27 |
| Summary: | summary |