Stimucath Continuous Nerve Block Set, Product Number Ab-05000

• • Terminated Z-0309-2012 FDA Unclassified (pre-2012) ·initiated 20 Jun 2011

  Some of the outer trays used in the packaging of the ASK-19608-SFH Continuous Nerve Block Kits, lot # MF0127039 were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed.

• • Terminated Z-0852-05 FDA Unclassified (pre-2012) ·initiated 17 Feb 2005

  Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.

510(k) Number

K021567 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• Needleless Injection Cannula

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• Arrow Echogenic Introducer Needle Component

  Class II

  FDA 510(k) K071998 Active Cleared 26 Sep 2007

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