INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir

FDA 510(k) K190690 · Sorin Group Italia S.R.L.

Substantially Equivalent

510(k) numberK190690

Submission

Device name
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
Applicant
Sorin Group Italia S.R.L.
Mirandola, IT
Received
March 18, 2019
Decision date
April 13, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DTZ – Oxygenator, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4350
Specialty
Cardiovascular
Life-sustaining
Yes

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K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…DTZ · Traditional Eurosets S.R.L12/12/2025SE
K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ · Traditional Eurosets S.R.L11/24/2025SE
K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional Qura S.R.L09/12/2024SE
K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional Medtronic Perfusion Systems07/10/2024SE
K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special Medtronic, Inc.06/12/2024SE
K231652D100 Kids; D101 KidsDTZ · Special Sorin Group Italia S.R.L.11/16/2023SE
K231773Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional Qura S.R.L11/08/2023SE
K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional Chalice Medical , Ltd.11/01/2023SE

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K242953KIDS Arterial FiltersDTM · Special 12/20/2024SE
K242092MICRO Arterial FiltersDTM · Special 11/18/2024SE
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Questions and answers

When was INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir cleared by the FDA?

INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir (K190690) received a 510(k) decision of Substantially Equivalent on April 13, 2019, 26 days after the submission was received.

What is the product code of K190690?

The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.