D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K072091 ↗

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

See all devices from Sorin Group Italia S.R.L. →

• What is the D101 Kids Infant Hollow Fiber Membrane Oxygenator used for?

  The D101 Kids Infant Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass device designed for pediatric patients. It facilitates gas exchange during cardiac procedures and includes an integrated hardshell cardiotomy/venous reservoir for blood collection and management.

• Is the D101 Kids Infant Hollow Fiber Membrane Oxygenator single-use or reusable?

  The D101 Kids Infant Hollow Fiber Membrane Oxygenator is supplied as a single-use product and is intended for use in cardiovascular surgical settings. It should not be reused on different patients.

• What regulatory approvals does the D101 Kids Infant Hollow Fiber Membrane Oxygenator have?

  The device received FDA 510(k) clearance with decision code SESE on October 29, 2007, and is classified under product code DTZ. It is manufactured by Sorin Group Italia S.R.L. and is not indicated for MRI use.

• What sizes and models of the D101 Kids Infant Hollow Fiber Membrane Oxygenator are available?

  The device is specifically designed for pediatric patients as indicated by its name 'Kids Infant'. The available model is the D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir, which is the only model mentioned in the device data.