DeviceClearance

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM— 510(k) K071358

Substantially Equivalent

Radiant Medical

FDA 510(k) clearance K071358 for REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM, Substantially Equivalent on 2007-06-01. Applicant: Radiant Medical.

Clearance details

Applicant
Radiant Medical
Product code
Code NCX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Redwood City, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code NCX

product code NCX
Death
30
Malfunction
2,302
Total
2,332

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.