FOGARTY-CHIN PERIPHERAL DILATION CATH— 510(k) K832474

Name: FDA 510(k) clearance K832474
Creator: U.S. Food and Drug Administration
Published: 1983-09-29

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K832474 for FOGARTY-CHIN PERIPHERAL DILATION CATH, Substantially Equivalent on 1983-09-29. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1983-07-26
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER1987-12-03
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K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-21987-09-15
K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP1987-04-17
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Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.