The following data is part of a premarket notification filed by Stanco Medical, Inc. with the FDA for Vascular Catheter Wireguides.
| Device ID | K802260 |
| 510k Number | K802260 |
| Device Name: | VASCULAR CATHETER WIREGUIDES |
| Classification | Wire, Guide, Catheter |
| Applicant | STANCO MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-16 |
| Decision Date | 1980-10-10 |