15F X 55cm Excell Split -Tip Catheter, Models 10300606, 10300706

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K040992 ↗

FDA Product Code

MSD

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

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  FDA 510(k) K081904 Active Cleared 23 Sep 2008

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  Class II

  FDA 510(k) K051280 Active Cleared 30 Nov 2005

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