MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG— 510(k) K861434

Substantially Equivalent

Churchill Corp.

FDA 510(k) clearance K861434 for MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG, Substantially Equivalent on 1986-05-01. Applicant: Churchill Corp..

Clearance details

Applicant: Churchill Corp.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1986-04-17
Decision date: 1986-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

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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.