Cleared Traditional

K964197 - IMPRA CARBOFLO EPTFE VASCULAR GRAFT

K964197 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 73-day FDA review.

K964197 · Impra, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 1997
Decision
73d
Days
Class 2
Risk

K964197 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 January 2, 1997 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Impra, Inc. devices

FDA 510(k) Submission Details - K964197

510(k) Number K964197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1996
Decision Date January 02, 1997
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 K964197.
VASCUTEK TWILLWEAVE VASCULAR GRAFT
K964959 · Vascutek, Ltd. · Mar 1997
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
K962639 · Impra, Inc. · Oct 1996
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