INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)— 510(k) K964021

Substantially Equivalent

Baxter Edwards

FDA 510(k) clearance K964021 for INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099), Substantially Equivalent on 1997-03-27. Applicant: Baxter Edwards.

Clearance details

Applicant: Baxter Edwards
Product code: Code HCG
Advisory panel: Neurology
Date received: 1996-10-07
Decision date: 1997-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.