Cleared Traditional

K922025 - ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF

K922025 is an FDA 510(k) clearance for ANASTOMART(TM) CORONARY BYPASS GRAFT MA..., manufactured by Pioneering Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K922025 · Pioneering Technologies, Inc. · Cardiovascular device
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Sep 1992
Decision
168d
Days
Class 2
Risk

K922025 is an FDA 510(k) clearance for the ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Pioneering Technologies, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on September 22, 1992 after a review of 168 days - an extended review 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: 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 Pioneering Technologies, Inc. devices

FDA 510(k) Submission Details - K922025

510(k) Number K922025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1992
Decision Date September 22, 1992
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
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 154
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K922025.
BARD PTFE VASCULAR GRAFT
K933204 · C.R. Bard, Inc. · Oct 1993
ATRIUM'S HYBRID PTFE
K925123 · Atrium Medical Corp. · May 1993
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
K922905 · W.L. Gore & Associates, Inc. · Nov 1992
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
K914116 · Medtronic Vascular · Nov 1991
GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
K914447 · W.L. Gore & Associates, Inc. · Nov 1991
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
K910863 · Vascutek, Ltd. · Apr 1991