K090325

Substantially Equivalent

JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)

Applicant: Pathway Medical Technologies, Inc.
Product code: MCW
Advisory panel: Cardiovascular
Date received: 2009-02-09
Decision date: 2009-03-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Kirkland, WA, US

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.