JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)— 510(k) K093918

Substantially Equivalent

Pathway Medical Technologies, Inc.

FDA 510(k) clearance K093918 for JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE), Substantially Equivalent on 2010-01-21. Applicant: Pathway Medical Technologies, Inc..

Clearance details

Applicant: Pathway Medical Technologies, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2009-12-22
Decision date: 2010-01-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Kirkland, WA, US

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.