JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100— 510(k) K082664

Substantially Equivalent

Pathway Medical Technologies, Inc.

FDA 510(k) clearance K082664 for JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100, Substantially Equivalent on 2008-10-06. Applicant: Pathway Medical Technologies, Inc..

Clearance details

Applicant: Pathway Medical Technologies, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2008-09-12
Decision date: 2008-10-06
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.