Prowler Infusion Catheters with Pre-Shaped Tips

• • Terminated Z-0018-04 FDA Unclassified (pre-2012) ·initiated 19 Oct 2001 ·on shared 510(k) K003925

  These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.

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

510(k) Number

K003925 ↗

FDA Product Code

KRA

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips

  Class II

  FDA 510(k) K020680 Active Cleared 27 Mar 2002

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