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Percutaneous Introducer Kit

by Device Labs, Inc. 510(k)

Active United States

510(k) K902135

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK902135 Date1 Aug 1990ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

13 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1150-06 FDA Unclassified (pre-2012) initiated 22 May 2006
    • Terminated Z-1152-06 FDA Unclassified (pre-2012) initiated 22 May 2006
    • Terminated Z-1149-06 FDA Unclassified (pre-2012) initiated 22 May 2006
    • Terminated Z-1151-06 FDA Unclassified (pre-2012) initiated 22 May 2006
    • Terminated Z-1153-06 FDA Unclassified (pre-2012) initiated 22 May 2006
    • Terminated Z-1148-06 FDA Unclassified (pre-2012) initiated 22 May 2006

    The 9F device may contain a 10 F sheath instead of the 9F

  • 3 recalls, same reason

    • Terminated Z-1096-05 FDA Unclassified (pre-2012) initiated 30 Jun 2005 on shared 510(k) K902135
    • Terminated Z-1093-05 FDA Unclassified (pre-2012) initiated 30 Jun 2005 on shared 510(k) K902135
    • Terminated Z-1097-05 FDA Unclassified (pre-2012) initiated 30 Jun 2005 on shared 510(k) K902135

    The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use

    • Terminated Z-1092-05 FDA Unclassified (pre-2012) initiated 30 Jun 2005 on shared 510(k) K902135

    The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use

  • 3 recalls, same reason

    • Terminated Z-1094-05 FDA Unclassified (pre-2012) initiated 30 Jun 2005 on shared 510(k) K902135
    • Terminated Z-1095-05 FDA Unclassified (pre-2012) initiated 30 Jun 2005 on shared 510(k) K902135
    • Terminated Z-1098-05 FDA Unclassified (pre-2012) initiated 30 Jun 2005 on shared 510(k) K902135

    The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESK Substantially Equivalent — Kit

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