ADD-A-VIAL SOLUTION TRANSFER DEVICE— 510(k) K843639

Name: FDA 510(k) clearance K843639
Creator: U.S. Food and Drug Administration
Published: 1985-01-14

Substantially Equivalent

American Mcgaw

FDA 510(k) clearance K843639 for ADD-A-VIAL SOLUTION TRANSFER DEVICE, Substantially Equivalent on 1985-01-14. Applicant: American Mcgaw. Device class: 2.

Clearance details

Applicant: American Mcgaw
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1984-09-17
Decision date: 1985-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Mcgaw

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K853549 — MCGAW/DROP WATCH FLOW MONITOR1985-11-12
K843954 — MIXING CONTAINER1984-11-28
K841729 — ACCUPRO ENTERAL FEEDING PUMP1984-06-01
K840212 — CONCENTRATED PLATELET ADMIN. SET1984-03-06
K840388 — PAB IV CONTAINER1984-03-06

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.