Cleared Traditional

NuCath Wedge Pressure Catheter

K213666 · Pfm Medical, Inc. · Cardiovascular
Oct 2022
Decision
318d
Days
Class 2
Risk

About This 510(k) Submission

K213666 is an FDA 510(k) clearance for the NuCath Wedge Pressure Catheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 6, 2022, 318 days after receiving the submission on November 22, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K213666 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2021
Decision Date October 06, 2022
Days to Decision 318 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

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