The following data is part of a premarket notification filed by Advanced Catheter Therapies, Inc. with the FDA for Occlusion Perfusion Catheter.
| Device ID | K130525 |
| 510k Number | K130525 |
| Device Name: | OCCLUSION PERFUSION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ADVANCED CATHETER THERAPIES, INC. 7401 104TH AVE Kenosha, WI 53142 |
| Contact | Chris Henza |
| Correspondent | Chris Henza ADVANCED CATHETER THERAPIES, INC. 7401 104TH AVE Kenosha, WI 53142 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-28 |
| Decision Date | 2013-10-03 |