Cleared Traditional

D?Kaptain PTA High Pressure Balloon Dilatation Catheter

K214009 · Dk Medical Technology Co., Ltd. · Cardiovascular
Apr 2023
Decision
516d
Days
Class 2
Risk

About This 510(k) Submission

K214009 is an FDA 510(k) clearance for the D?Kaptain PTA High Pressure Balloon Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Dk Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on April 5, 2023, 516 days after receiving the submission on November 5, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K214009 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2021
Decision Date April 05, 2023
Days to Decision 516 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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