INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250— 510(k) K092666

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K092666 for INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250, Substantially Equivalent on 2009-09-30. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code HCG
Advisory panel: Neurology
Date received: 2009-08-31
Decision date: 2009-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, 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.