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Hemashield Gold Woven Double Velour Vascular Graft - Branch Graft

by Boston Scientific/Medi-Tech

510(k) K012952

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK012952 Date2 Oct 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2061-2010 FDA Unclassified (pre-2012) initiated 24 May 2010

    Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DSY
Device Class
Class II
Regulation
21 CFR Part 870.3450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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