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Glycar Pericardial Patch

by Glycar, Inc.

510(k) K963967

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 · Traditional NumberK963967 Date31 Oct 1997ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0532-2026 FDA Class I initiated 9 Oct 2025
    • Ongoing Z-0531-2026 FDA Class I initiated 9 Oct 2025

    The impacted lot may not meet the required tensile strength specification.

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  • Withdrawn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
DXZ
Device Class
Class II
Regulation
21 CFR Part 870.3470
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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