EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189— 510(k) K013789

Substantially Equivalent

Boston Scientific, Target

FDA 510(k) clearance K013789 for EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189, Substantially Equivalent on 2001-12-06. Applicant: Boston Scientific, Target.

Clearance details

Applicant: Boston Scientific, Target
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2001-11-14
Decision date: 2001-12-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.