TUBING PACK, EXTRACORPOREAL, H-3000— 510(k) K770720

Name: FDA 510(k) clearance K770720
Creator: U.S. Food and Drug Administration
Published: 1977-08-04

Substantially Equivalent

William Harvey Life Products Corp.

FDA 510(k) clearance K770720 for TUBING PACK, EXTRACORPOREAL, H-3000, Substantially Equivalent on 1977-08-04. Applicant: William Harvey Life Products Corp.. Device class: 2.

Clearance details

Applicant: William Harvey Life Products Corp.
Product code: Code BYS
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 1977-04-18
Decision date: 1977-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BYS

product code BYS

Death: 5
Other: 1
Total: 6

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.