Cleared Traditional

K180957 - exGraft

K180957 is an FDA 510(k) clearance for exGraft, manufactured by Peca Labs. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K180957 · Peca Labs · Cardiovascular device
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Aug 2018
Decision
131d
Days
Class 2
Risk

K180957 is an FDA 510(k) clearance for the exGraft, exGraft Carbon ePTFE Vascular Grafts. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Peca Labs (Pittsburgh, US). The FDA issued a Cleared decision on August 21, 2018 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Peca Labs devices

FDA 510(k) Submission Details - K180957

510(k) Number K180957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2018
Decision Date August 21, 2018
Days to Decision 131 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 125d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K180957.
Vascutek Gelsoft Plus ERS Vascular Graft
K202703 · Vascutek, Ltd. · Apr 2021
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
K202471 · Peca Labs · Dec 2020
exGraft, exGraft Carbon
K183613 · Peca Labs · Apr 2019
HeRO Graft
K172637 · Merit Medical Systems, Inc. · Nov 2017
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
K162803 · Vascutek, Ltd. · Jul 2017
Gelweave Vascular Grafts
K162794 · Vascutek, Ltd. · Jun 2017