Hollow Fiber Membrane Oygenator Quadrox Hmo 1010

FDA 510(k) K992559 · Jostra Bentley

Substantially Equivalent

510(k) numberK992559

Submission

Device name
Hollow Fiber Membrane Oygenator Quadrox Hmo 1010
Applicant
Jostra Bentley
Newark, DE, US
Received
July 30, 1999
Decision date
September 20, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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More from Chalice Medical , Ltd.

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Questions and answers

When was Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 cleared by the FDA?

Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 (K992559) received a 510(k) decision of Substantially Equivalent on September 20, 1999, 52 days after the submission was received.

What is the product code of K992559?

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