Cleared Traditional

K962639 - IMPRA CARBOFLO EPTFE VASCULAR GRAFT

K962639 is an FDA 510(k) clearance for IMPRA CARBOFLO EPTFE VASCULAR GRAFT, manufactured by Impra, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K962639 · Impra, Inc. · Cardiovascular device
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Oct 1996
Decision
90d
Days
Class 2
Risk

K962639 is an FDA 510(k) clearance for the IMPRA CARBOFLO EPTFE VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on October 3, 1996 after a review of 90 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 Impra, Inc. devices

FDA 510(k) Submission Details - K962639

510(k) Number K962639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received July 05, 1996
Decision Date October 03, 1996
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 128
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K962639.
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
K964665 · Carbomedics, Inc. · Feb 1997
HEMASHIELD VANTAGE (VASCULAR GRAFT
K961847 · Meadox Medicals, Div. Boston Scientific Corp. · Jan 1997
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K964197 · Impra, Inc. · Jan 1997
BARD GRAFT SIZER
K961134 · C.R. Bard, Inc. · Jun 1996
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
K955460 · Meadox Medicals, Div. Boston Scientific Corp. · May 1996
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
K960706 · Carbomedics, Inc. · Apr 1996