Tubing Pack, Extracorporeal, H-3000

FDA 510(k) K770720 · William Harvey Life Products Corp.

Substantially Equivalent

510(k) numberK770720

Submission

Device name
Tubing Pack, Extracorporeal, H-3000
Applicant
William Harvey Life Products Corp.
Mchenry, IL, US
Received
April 18, 1977
Decision date
August 4, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYS – Oxygenator, Long Term Support Greater Than 6 Hours
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4100
Specialty
Cardiovascular
Life-sustaining
Yes

Other 510(k)s with product code BYS

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K232767Nautilus VF ECMO OxygenatorBYS · Special Mc3, Inc.10/04/2023SE
K191935Nautilus Smart ECMO ModuleBYS · Traditional Mc3 Incorporated04/09/2020SE

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Questions and answers

When was Tubing Pack, Extracorporeal, H-3000 cleared by the FDA?

Tubing Pack, Extracorporeal, H-3000 (K770720) received a 510(k) decision of Substantially Equivalent on August 4, 1977, 108 days after the submission was received.

What is the product code of K770720?

The FDA product code is BYS – Oxygenator, Long Term Support Greater Than 6 Hours, a Class II (moderate risk) device regulated under 21 CFR 870.4100.