Cleared Traditional

CHASE CARDIOVASCULAR PATCH KIT

K022093 · Chase Medical, Inc. · Cardiovascular
Sep 2002
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K022093 is an FDA 510(k) clearance for the CHASE CARDIOVASCULAR PATCH KIT, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Chase Medical, Inc. (Richardson, US). The FDA issued a Cleared decision on September 20, 2002, 85 days after receiving the submission on June 27, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number K022093 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2002
Decision Date September 20, 2002
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3470

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