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Merit Mak (Mini Access Kit)

by Merit Medical Systems, Inc.

510(k) K031691

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 · Abbreviated NumberK031691 Date3 Sep 2003ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1309-04 FDA Unclassified (pre-2012) initiated 20 Jul 2004
    • Terminated Z-1311-04 FDA Unclassified (pre-2012) initiated 20 Jul 2004
    • Terminated Z-1310-04 FDA Unclassified (pre-2012) initiated 20 Jul 2004

    Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.

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  • Withdrawn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
DRE
Device Class
Class II
Regulation
21 CFR Part 870.1310
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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