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510(k) Data Aggregation
K Number
K041736Device Name
PFA PATCH
Manufacturer
PERITEC BIOSCIENCES, LLC.
Date Cleared
2005-01-13
(199 days)
Product Code
DXZ
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
PERITEC BIOSCIENCES, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PFA patch is designed for use in peripheral arteries as a patch following arterial endarterectomy and as a tissue pledget for arterial surgery. It also can be used as a buttress for over sewing suture lines.
The PFA Patch is intended for peripheral vascular reconstruction of blood vessels and arteriovenous (A/V) revisions.
Device Description
The PFA Vascular Patch is a cross-linked piece of bovine peritoneal / fascia tissue and is available in the following sizes:
0.8 cm x 3.0 cm 1.0 cm x 8.0 cm 2.0 cm x 9.0 cm
The device is packaged in an industry standard polymeric vial with a threaded cap sealed by a plastic shrink wrap. The tissue is packaged with a solution of glutaraldehyde. The sealed container is placed in a shelf carton with the Instructions for Use. The shelf carton contains a freeze warning indicator. The product is provided sterile and is intended for single use only. It is not intended to be resterilized or reused.
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