The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil(r) Guidewire.
| Device ID | K945934 |
| 510k Number | K945934 |
| Device Name: | URESIL(R) GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | Matthew Curtis |
| Correspondent | Matthew Curtis URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-05 |
| Decision Date | 1995-07-10 |