JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE— 510(k) K945720

Name: FDA 510(k) clearance K945720
Creator: U.S. Food and Drug Administration
Published: 1995-03-29

Substantially Equivalent

Jostra Bentley

FDA 510(k) clearance K945720 for JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE, Substantially Equivalent on 1995-03-29. Applicant: Jostra Bentley. Device class: 2.

Clearance details

Applicant: Jostra Bentley
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 1994-11-21
Decision date: 1995-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.