Cleared Abbreviated

K983861 - DISTAFLO BYPASS GRAFT

K983861 is an FDA 510(k) clearance for DISTAFLO BYPASS GRAFT, manufactured by Impra, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Abbreviated 510(k) pathway after a 22-day FDA review.

K983861 · Impra, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
22d
Days
Class 2
Risk

K983861 is an FDA 510(k) clearance for the DISTAFLO BYPASS 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 November 24, 1998 after a review of 22 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Impra, Inc. devices

FDA 510(k) Submission Details - K983861

510(k) Number K983861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1998
Decision Date November 24, 1998
Days to Decision 22 days
Submission Type Abbreviated
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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Standards-based clearance path.

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 K983861.
UNI-GRAFT K DV VASCULAR GRAFT
K991813 · Atrium Medical Corp. · Jun 1999
BI-DIRECTIONAL TUNNELER
K991027 · Impra, Inc. · Apr 1999
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
K984182 · Possis Medical, Inc. · Feb 1999
IMPRA HIGH POROSITY GRAFT
K983064 · Impra, Inc. · Nov 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981079 · Impra, Inc. · May 1998
UNI-GRAFT K DV
K963790 · Atrium Medical Corp. · Jul 1997