The following data is part of a premarket notification filed by Vascon Llc with the FDA for Vascon Polaris Guiding Catheter.
| Device ID | K043387 |
| 510k Number | K043387 |
| Device Name: | VASCON POLARIS GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | VASCON LLC 9344 NW 13TH STREET Miami, FL 33172 |
| Contact | Stephen F Vadas |
| Correspondent | Stephen F Vadas VASCON LLC 9344 NW 13TH STREET Miami, FL 33172 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-09 |
| Decision Date | 2005-02-16 |
| Summary: | summary |