The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Fox Sv Pta Catheter.
Device ID | K072824 |
510k Number | K072824 |
Device Name: | FOX SV PTA CATHETER |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | ABBOTT LABORATORIES 3200 Lakeside Drive Santa Clara, CA 95054 |
Contact | George J Prendergast |
Correspondent | George J Prendergast ABBOTT LABORATORIES 3200 Lakeside Drive 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 | 2007-10-02 |
Decision Date | 2007-10-23 |
Summary: | summary |