Cleared Traditional

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts

K233783 · Peca Labs, Inc. · Cardiovascular

Jan 2024

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K233783 is an FDA 510(k) clearance for the exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Peca Labs, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on January 17, 2024, 51 days after receiving the submission on November 27, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number	K233783 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 2023
Decision Date	January 17, 2024
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF