Cleared Traditional

Zoom 6F Insert Catheters

K233975 · Imperative Care, Inc. · Cardiovascular
Apr 2024
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K233975 is an FDA 510(k) clearance for the Zoom 6F Insert Catheters, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on April 2, 2024, 109 days after receiving the submission on December 15, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K233975 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2023
Decision Date April 02, 2024
Days to Decision 109 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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