Sigma's Calcium Procedure No. 587

• • Terminated Z-1062-05 FDA Unclassified (pre-2012) ·initiated 27 May 2005 ·on shared 510(k) K871152

  Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.

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

510(k) Number

K871152 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class I

  FDA 510(k) K932067 Active Cleared 16 Jun 1993

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