510(k) K252512

Armada™ 14 NC PTA Catheter by ABBOTT MEDICAL — Product Code LIT

K252512 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Armada™ 14 NC PTA Catheter". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2026
Date Received
August 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type