The following data is part of a premarket notification filed by Advanced Catheter Therapies, Inc. with the FDA for Occlusion Perfusion Catheter.
| Device ID | K153488 |
| 510k Number | K153488 |
| Device Name: | Occlusion Perfusion Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Advanced Catheter Therapies, Inc. 25 E. Main Street, Suite 205 Chattanooga, TN 37408 |
| Contact | Paul Joseph Fitzpatrick |
| Correspondent | Jeff Smith The Braveheart Group, Inc 3424 Glendon Drive Chattanooga, TN 37411 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-04 |
| Decision Date | 2016-02-25 |