Cleared Traditional

Guiding Catheter

K210009 · CenterPoint Systems, LLC · Cardiovascular
Nov 2021
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K210009 is an FDA 510(k) clearance for the Guiding Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by CenterPoint Systems, LLC (West Valley City, US). The FDA issued a Cleared decision on November 24, 2021, 324 days after receiving the submission on January 4, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K210009 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2021
Decision Date November 24, 2021
Days to Decision 324 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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