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510(k) Data Aggregation
K Number
K233783Device Name
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
Manufacturer
PECA Labs, Inc.
Date Cleared
2024-01-17
(51 days)
Product Code
DSY, DYF
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
PECA Labs, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
Device Description
The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
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