The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Fusion Quattro Extraction Balloon Xl.
| Device ID | K063677 |
| 510k Number | K063677 |
| Device Name: | FUSION QUATTRO EXTRACTION BALLOON XL |
| 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 | Scottie Fariole |
| Correspondent | Scottie Fariole 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 | 2006-12-11 |
| Decision Date | 2007-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002482265 | K063677 | 000 |
| 00827002482258 | K063677 | 000 |
| 00827002319226 | K063677 | 000 |
| 00827002319219 | K063677 | 000 |