CHURCHILL INTER-CARDIAC SUCKER— 510(k) K872043

Name: FDA 510(k) clearance K872043
Creator: U.S. Food and Drug Administration
Published: 1987-09-30

Substantially Equivalent

Churchill Corp.

FDA 510(k) clearance K872043 for CHURCHILL INTER-CARDIAC SUCKER, Substantially Equivalent on 1987-09-30. Applicant: Churchill Corp.. Device class: 2.

Clearance details

Applicant: Churchill Corp.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 1987-05-27
Decision date: 1987-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Churchill Corp.

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K880025 — CHURCHILL 0.22 MICRON LIQUID FILTER SETS1988-04-14
K880026 — CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS1988-04-14
K880051 — ENTERAL BAG/SET1988-04-14
K880027 — CHURCHILL 1.2 MICRON LIQUID FILTER SET1988-04-13
K870395 — CHURCHILL PARENTERAL NUTRITION BAG - EVA1987-10-15

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.