The following data is part of a premarket notification filed by Abbott Vascular-vascular Solutions with the FDA for Viatrac 14 Plus Peripheral Dilation Catheter.
Device ID | K072798 |
510k Number | K072798 |
Device Name: | VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. Santa Clara, CA 95054 |
Contact | Danielle M Taylor |
Correspondent | Danielle M Taylor ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. Santa Clara, CA 95054 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-01 |
Decision Date | 2008-01-31 |
Summary: | summary |