Cleared Traditional

CHASE CARDIOVASCULAR PATCH

K012248 · Chase Medical, Inc. · Cardiovascular
Aug 2001
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K012248 is an FDA 510(k) clearance for the CHASE CARDIOVASCULAR PATCH, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Chase Medical, Inc. (Athens, US). The FDA issued a Cleared decision on August 10, 2001, 24 days after receiving the submission on July 17, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number K012248 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2001
Decision Date August 10, 2001
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

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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