Cleared Traditional

HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH

K962342 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular
Sep 1996
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K962342 is an FDA 510(k) clearance for the HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on September 10, 1996, 84 days after receiving the submission on June 18, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number K962342 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1996
Decision Date September 10, 1996
Days to Decision 84 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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