The following data is part of a premarket notification filed by Advanced Catheter Therapies, Inc. with the FDA for Occlusion Perfusion Catheter.
| Device ID | K151554 |
| 510k Number | K151554 |
| Device Name: | Occlusion Perfusion Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | ADVANCED CATHETER THERAPIES, INC. 25E. MAIN ST. SUITE 205 Chattanooga, TN 37408 |
| Contact | Paul Joseph Fitzpatric |
| Correspondent | Chris Henza REGULATORY COMPLIANCE ASSOCIATES, INC. 10411 CORPORATE DRIVE, SUITE 102 Pleasant Prarie, WI 53158 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-09 |
| Decision Date | 2015-09-15 |