Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K081049 ↗

FDA Product Code

DRA

Device Class

Class II

Regulation

21 CFR Part 870.1280

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K070357 Active Cleared 28 Dec 2007