The following data is part of a premarket notification filed by Abbott Laboratories Inc with the FDA for Fox Plus Pta Catheter.
| Device ID | K040954 |
| 510k Number | K040954 |
| Device Name: | FOX PLUS PTA CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ABBOTT LABORATORIES INC 800 SAGINAW DRIVE Redwood City, CA 94063 |
| Contact | Joanna Kuskowski |
| Correspondent | Joanna Kuskowski ABBOTT LABORATORIES INC 800 SAGINAW DRIVE Redwood City, CA 94063 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-13 |
| Decision Date | 2004-05-11 |
| Summary: | summary |