JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM— 510(k) K130637

Substantially Equivalent

Medrad, Inc.

FDA 510(k) clearance K130637 for JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM, Substantially Equivalent on 2013-04-10. Applicant: Medrad, Inc..

Clearance details

Applicant: Medrad, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2013-03-11
Decision date: 2013-04-10
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.