ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM— 510(k) K042218

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K042218 for ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM, Substantially Equivalent on 2004-08-31. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2004-08-05
Decision date: 2004-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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Adverse events under product code NTE

product code NTE

Death: 28
Injury: 1,348
Malfunction: 771
Total: 2,147

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.