The following data is part of a premarket notification filed by Abbott Vascular-vascular Solutions with the FDA for Modification To: Fox Plus Pta Catheter.
| Device ID | K080264 |
| 510k Number | K080264 |
| Device Name: | MODIFICATION TO: FOX PLUS PTA CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Contact | Ivalee Cohen |
| Correspondent | Ivalee Cohen ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. Santa Clara, CA 95054 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-01 |
| Decision Date | 2008-03-26 |
| Summary: | summary |