Cleared Traditional

K925123 - ATRIUM'S HYBRID PTFE

K925123 is an FDA 510(k) clearance for ATRIUM'S HYBRID PTFE, manufactured by Atrium Medical Corp.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K925123 · Atrium Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
226d
Days
Class 2
Risk

K925123 is an FDA 510(k) clearance for the ATRIUM'S HYBRID PTFE. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hollis, US). The FDA issued a Cleared decision on May 27, 1993 after a review of 226 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 Atrium Medical Corp. devices

FDA 510(k) Submission Details - K925123

510(k) Number K925123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received October 13, 1992
Decision Date May 27, 1993
Days to Decision 226 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
101d slower than avg
Panel avg: 125d · This submission: 226d
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 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K925123.
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
K933590 · Baxter Healthcare Corp · Jan 1994
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
K933943 · W.L. Gore & Associates, Inc. · Dec 1993
BARD PTFE VASCULAR GRAFT
K933204 · C.R. Bard, Inc. · Oct 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