Cleared Traditional

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter

K221832 · Cordis US Corp · Cardiovascular
Aug 2022
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K221832 is an FDA 510(k) clearance for the SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Cordis US Corp (Miami Lakes, US). The FDA issued a Cleared decision on August 22, 2022, 60 days after receiving the submission on June 23, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K221832 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2022
Decision Date August 22, 2022
Days to Decision 60 days
Submission Type Traditional
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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