The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Armada 35/35ll Pta Catheter.
Device ID | K111899 |
510k Number | K111899 |
Device Name: | ARMADA 35/35LL PTA CATHETER |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
Contact | Laarni Ricafort |
Correspondent | Laarni Ricafort Abbott Vascular 3200 Lakeside Drive 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 | 2011-07-05 |
Decision Date | 2011-10-03 |
Summary: | summary |