Acute and Chronic Catheter Repair Kit

• • Terminated Z-1955-2019 FDA Class II ·initiated 29 Apr 2019 ·on shared 510(k) K092797

  The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

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

510(k) Number

K092797 ↗

FDA Product Code

NFK

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

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