The following data is part of a premarket notification filed by Abbott Laboratories (perclose, Inc.) with the FDA for Fox Sv Pta Catheter (82xxx Series). Fox Plus Pta Catheter (12xxx Series).
| Device ID | K051519 |
| 510k Number | K051519 |
| Device Name: | FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | ABBOTT LABORATORIES (PERCLOSE, INC.) 400 Saginaw Drive Redwood City, CA 94063 |
| Contact | Ann E Leonard |
| Correspondent | Ann E Leonard ABBOTT LABORATORIES (PERCLOSE, INC.) 400 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 | 2005-06-08 |
| Decision Date | 2005-06-21 |
| Summary: | summary |