MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM— 510(k) K052166

Substantially Equivalent

Guidant Corporation

FDA 510(k) clearance K052166 for MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM, Substantially Equivalent on 2005-08-18. Applicant: Guidant Corporation.

Clearance details

Applicant: Guidant Corporation
Product code: Code NTE
Advisory panel: Cardiovascular
Date received: 2005-08-09
Decision date: 2005-08-18
Decision: Substantially Equivalent
Clearance type: Special
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.