The following data is part of a premarket notification filed by Velocimed Inc. with the FDA for Venture Wire Control Catheter.
| Device ID | K040922 |
| 510k Number | K040922 |
| Device Name: | VENTURE WIRE CONTROL CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | VELOCIMED INC. 11400 73RD AVENUE NORTH SUITE 134 Mineapolis, MN 55369 -5567 |
| Contact | Sew-wah Tay |
| Correspondent | Sew-wah Tay VELOCIMED INC. 11400 73RD AVENUE NORTH SUITE 134 Mineapolis, MN 55369 -5567 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-08 |
| Decision Date | 2004-08-18 |
| Summary: | summary |