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Softouch Diagnostic Intravascular Catheter

by Mallinckrodt Medical 2 variants

510(k) K943739

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 · Traditional NumberK943739 Date15 Nov 1994ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0045-2014 FDA Class II initiated 13 Sep 2013

    4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.

    • Terminated Z-1408-2013 FDA Class II initiated 2 May 2013

    Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.

  • 2 recalls, same reason

    • Terminated Z-0158-04 FDA Unclassified (pre-2012) initiated 5 Nov 2003
    • Terminated Z-0159-04 FDA Unclassified (pre-2012) initiated 5 Nov 2003

    Angiographic catheter tips may separate during use.

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  • Withdrawn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
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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