Jostra HL-15 Modular Heart-Lung Machine (Hereinafter Called the HL-15 or the Device

FDA 510(k) K945720 · Jostra Bentley

Substantially Equivalent

510(k) numberK945720

Submission

Device name
Jostra HL-15 Modular Heart-Lung Machine (Hereinafter Called the HL-15 or the Device
Applicant
Jostra Bentley
Austin, TX, US
Received
November 21, 1994
Decision date
March 29, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DWC – Controller, Temperature, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4250
Specialty
Cardiovascular
Life-sustaining
Yes

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was Jostra HL-15 Modular Heart-Lung Machine (Hereinafter Called the HL-15 or the Device cleared by the FDA?

Jostra HL-15 Modular Heart-Lung Machine (Hereinafter Called the HL-15 or the Device (K945720) received a 510(k) decision of Substantially Equivalent on March 29, 1995, 128 days after the submission was received.

What is the product code of K945720?

The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.