Impact Balloon Dilation Catheter

• • Terminated Z-0509-2010 FDA Unclassified (pre-2012) ·initiated 23 Sep 2009 ·via K983373, on the same 510(k)

  The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never used. The customer referred to it as looking like "paint crackle." The risk is that for continued sterility to be assured, the packaging must remain intact.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K983373 ↗

FDA Product Code

KNQ

Device Class

Class II

Regulation

21 CFR Part 876.5365

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Celsite, Models ST401L, ST405L

  Class II

  FDA 510(k) K994111 Active Cleared 3 Jan 2000