THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER— 510(k) K131300

Substantially Equivalent

Access Scientific, LLC

FDA 510(k) clearance K131300 for THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER, Substantially Equivalent on 2013-06-07. Applicant: Access Scientific, LLC.

Clearance details

Applicant: Access Scientific, LLC
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2013-05-07
Decision date: 2013-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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.