Cleared Traditional

K955349 - HEMASHIELD KNITTED DOUBLE VELOUR CARDIO...

K955349 is the FDA 510(k) clearance for HEMASHIELD KNITTED DOUBLE VELOUR CARDIO... by Meadox Medicals, Div. Boston Scientific Corp.. It is a Class 2 Cardiovascular device (product code DXZ) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K955349 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
85d
Days
Class 2
Risk

K955349 is an FDA 510(k) clearance for the HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 85 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 Meadox Medicals, Div. Boston Scientific Corp. devices

Submission Details

510(k) Number K955349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1995
Decision Date February 14, 1996
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 44
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K955349.
UNI-GRAFT K DV PATCH
K992776 · Atrium Medical Corp. · Nov 1999
ACUSEAL CARDIOVASCULAR PATCH
K984526 · W.L. Gore & Associates, Inc. · Apr 1999
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
K962342 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1996
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
K953289 · Davis & Geck, Inc. · Aug 1995
POLYETHYLENE TEREPHTHALATE (PET) PLEDGET
K953425 · Davis & Geck, Inc. · Aug 1995
CVPRO CARDIOVASCULAR PATCH
K943736 · W.L. Gore & Associates, Inc. · Feb 1995