Cleared Special

Viatrac 14 Plus Peripheral Dilatation Catheter

K221057 · Abbott Vascular · Cardiovascular
May 2022
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K221057 is an FDA 510(k) clearance for the Viatrac 14 Plus Peripheral Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Abbott Vascular (S,Mta Clara, US). The FDA issued a Cleared decision on May 5, 2022, 24 days after receiving the submission on April 11, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K221057 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2022
Decision Date May 05, 2022
Days to Decision 24 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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