The following data is part of a premarket notification filed by Vascon Llc with the FDA for Vascon Neuropath Guiding Catheter.
| Device ID | K052004 |
| 510k Number | K052004 |
| Device Name: | VASCON NEUROPATH GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | VASCON LLC 4613 N. UNIVERSITY DRIVE SUITE 300 Coral Springs, FL 33067 |
| Contact | Roberta D Goode |
| Correspondent | Roberta D Goode VASCON LLC 4613 N. UNIVERSITY DRIVE SUITE 300 Coral Springs, FL 33067 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-25 |
| Decision Date | 2006-01-19 |
| Summary: | summary |