THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL— 510(k) K121748

Substantially Equivalent

Access Scientific, Inc.

FDA 510(k) clearance K121748 for THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL, Substantially Equivalent on 2012-07-27. Applicant: Access Scientific, Inc..

Clearance details

Applicant: Access Scientific, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2012-06-14
Decision date: 2012-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.