Skip to content

Enpath Deflectable Catheter

by Enpath Medical Incorporated 510(k)

Active United States

510(k) K043489

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK043489 Date19 May 2005ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

    • Terminated Z-0118-2007 FDA Unclassified (pre-2012) initiated 27 Jun 2006

    Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber.

    • Terminated Z-1573-05 FDA Unclassified (pre-2012) initiated 31 Aug 2005 on shared 510(k) K043489

    Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole.

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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Enpath Medical Incorporated