The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Tad And Tad Ii Tapered Guide Wires.
Device ID | K083732 |
510k Number | K083732 |
Device Name: | TAD AND TAD II TAPERED GUIDE WIRES |
Classification | Wire, Guide, Catheter |
Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
Contact | Nadine Smith |
Correspondent | Nadine Smith Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-16 |
Decision Date | 2009-02-25 |
Summary: | summary |