Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter— 510(k) K242289

Substantially Equivalent

Stryker Neurovascular

FDA 510(k) clearance K242289 for Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter, Substantially Equivalent on 2025-03-21. Applicant: Stryker Neurovascular.

Clearance details

Applicant
Stryker Neurovascular
Product code
Code QJP
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Fremont, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code QJP

product code QJP
Death
43
Injury
233
Malfunction
1,010
Total
1,286

Source: openFDA MAUDE database, through . 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.