The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Acrobat Calibrated Tip Wire Guide.
| Device ID | K142950 |
| 510k Number | K142950 |
| Device Name: | Acrobat Calibrated Tip Wire Guide |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Doris A Hawks |
| Correspondent | Doris A Hawks Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-10 |
| Decision Date | 2014-11-05 |
| Summary: | summary |