Cleared Traditional

IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) (K924360) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924360 · Impra, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
89d
Days
Class 2
Risk

K924360 is an FDA 510(k) clearance for the IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS). Classified as Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (product code DYF), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on November 25, 1992 after a review of 89 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

Submission Details

510(k) Number K924360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received August 28, 1992
Decision Date November 25, 1992
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYF Prosthesis, Vascular Graft, Of Less Then 6mm 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 - DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

All 9
Devices cleared under the same product code (DYF) and FDA review panel - the closest regulatory comparables to K924360.
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
K944844 · Baxter Healthcare Corp · Mar 1995
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
K940824 · W.L. Gore & Associates, Inc. · May 1994
FEP RINGED GORE-TEX VASCULAR GRAFT
K934726 · W.L. Gore & Associates, Inc. · Dec 1993
GORE-TEX VASCULAR GRAFT
K881732 · W.L. Gore & Associates, Inc. · May 1988
GORE-TEX VASCULAR GRAFT, FEP-RINGED
K842144 · W.L. Gore & Associates, Inc. · Oct 1984
FEP-RINGED GORE-TEX@ VASCULAR GRAFT
K821826 · W.L. Gore & Associates, Inc. · Dec 1982