0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter— 510(k) K183043

Substantially Equivalent

Imperative Care, Inc.

FDA 510(k) clearance K183043 for 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter, Substantially Equivalent on 2019-04-17. Applicant: Imperative Care, Inc..

Clearance details

Applicant: Imperative Care, Inc.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2018-11-02
Decision date: 2019-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campbell, CA, US

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Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

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.