The following data is part of a premarket notification filed by Velocimed Inc. with the FDA for Venture Wire Control Catheter, Model Wcc.
| Device ID | K042910 |
| 510k Number | K042910 |
| Device Name: | VENTURE WIRE CONTROL CATHETER, MODEL WCC |
| Classification | Catheter, Percutaneous |
| Applicant | VELOCIMED INC. 11400 73RD AVE NORTH STE 134 Minneapolis, MN 55369 |
| Contact | John Carline |
| Correspondent | John Carline VELOCIMED INC. 11400 73RD AVE NORTH STE 134 Minneapolis, MN 55369 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-21 |
| Decision Date | 2004-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20658220 | K042910 | 000 |
| M20658210 | K042910 | 000 |