Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate

• • Terminated Z-1919-2018 FDA Class II ·initiated 13 Mar 2018

  Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.

510(k) Number

K130433 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae

  Class II

  FDA 510(k) K972503 Active Cleared 26 Aug 1997

• Xtra

  Class II

  CE/MDR FDA 510(k) K112245 Active Cleared 6 Sep 2011

• XTRA Autotransfusion System (with XTRA Bowl sets)

  Class II

  FDA 510(k) K240584 Active Cleared 29 Apr 2024

• Card 43 Cardiotomy Reservoir with Phosphorylcholine Coating

  Class II

  FDA 510(k) K061527 Active Cleared 27 Jun 2006

• Retrograde Cardioplegia Cannula, Manual-Inflating, with Malleable or Guidwire Stylet

  Class II

  FDA 510(k) K010974 Active Cleared 18 Jun 2001

• PureFlex Arterial Cannulae

  Class II

  FDA 510(k) K180979 Active Cleared 16 Nov 2018

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