Cleared Traditional

VASCU-GUARD (K942010) - FDA 510(k) Clearance

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

K942010 · Bio-Vascular, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1994
Decision
73d
Days
Class 2
Risk

K942010 is an FDA 510(k) clearance for the VASCU-GUARD. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 7, 1994 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - 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 Bio-Vascular, Inc. devices

Submission Details

510(k) Number K942010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1994
Decision Date July 07, 1994
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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 - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 22
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K942010.
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc. · Nov 2000
ACUSEAL CARDIOVASCULAR PATCH
K984526 · W.L. Gore & Associates, Inc. · Apr 1999
CVPRO CARDIOVASCULAR PATCH
K943736 · W.L. Gore & Associates, Inc. · Feb 1995
GORE-TEX CARDIOVASCULAR PATCH
K940906 · W.L. Gore & Associates, Inc. · May 1994
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
K930950 · W.L. Gore & Associates, Inc. · Oct 1993
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
K914448 · W.L. Gore & Associates, Inc. · Nov 1991