SURGISIS PERIPHERAL VASCULAR PATCH

K001785 · Cook Biotech, Inc. · DXZ · Dec 27, 2000 · Cardiovascular

Device Facts

Record IDK001785
Device NameSURGISIS PERIPHERAL VASCULAR PATCH
ApplicantCook Biotech, Inc.
Product CodeDXZ · Cardiovascular
Decision DateDec 27, 2000
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.3470
Device ClassClass 2

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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