The following data is part of a premarket notification filed by Microvena Corp. with the FDA for Universal Delivery System Catheter.
| Device ID | K900657 |
| 510k Number | K900657 |
| Device Name: | UNIVERSAL DELIVERY SYSTEM CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-09 |
| Decision Date | 1990-05-09 |