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FDA 510(k)

JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE

K-Number: K945720 · 1995-03-29

ApplicantJostra Bentley
Decision Date1995-03-29
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Jostra Bentley. It received FDA 510(k) clearance on 1995-03-29 under 510(k) number K945720. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE?

JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE is a medical device that received FDA 510(k) clearance on 1995-03-29. The listed applicant is Jostra Bentley. The 510(k) number is K945720.

When did JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE receive FDA 510(k) clearance?

JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE received FDA 510(k) clearance on 1995-03-29, under 510(k) number K945720.

Who is the listed applicant for JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE?

The FDA 510(k) record lists Jostra Bentley as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE?

The FDA product code for JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE is DWC.

Related Clinical Trials

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Other records listing Jostra Bentley as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992559HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010K984338JOSTRA HL-20 TWIN PUMP

Related Devices (Code: DWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220635Heater-Cooler System 3TLivanova Deutschland, GmbHK212657Quantum Heater-CoolerSpectrum Medical , Ltd.K191402Heater-Cooler System 3TLivanova Deutschland, GmbHK130300HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AGK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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