The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Command 18 Guide Wire.
Device ID | K172073 |
510k Number | K172073 |
Device Name: | Hi-Torque Command 18 Guide Wire |
Classification | Wire, Guide, Catheter |
Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
Contact | Kathyrene Logrono |
Correspondent | Kathyrene Logrono 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 | 2017-07-10 |
Decision Date | 2017-08-25 |
Summary: | summary |