CANNULA, HUNTER-SESSIONS, SELF-RETAIN.— 510(k) K770068

Name: FDA 510(k) clearance K770068
Creator: U.S. Food and Drug Administration
Published: 1977-03-01

Substantially Equivalent

Barlow Mfg., Corp.

FDA 510(k) clearance K770068 for CANNULA, HUNTER-SESSIONS, SELF-RETAIN., Substantially Equivalent on 1977-03-01. Applicant: Barlow Mfg., Corp.. Device class: 2.

Clearance details

Applicant: Barlow Mfg., Corp.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 1977-01-12
Decision date: 1977-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.