The following data is part of a premarket notification filed by Microvena Corp. with the FDA for Ultra-select Ptca Guidewire.
| Device ID | K910280 |
| 510k Number | K910280 |
| Device Name: | ULTRA-SELECT PTCA GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MICROVENA CORP. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MICROVENA CORP. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-23 |
| Decision Date | 1991-04-19 |