ER-REBOA PLUS Catheter— 510(k) K193440

Substantially Equivalent

Prytime Medical Devices, Inc.

FDA 510(k) clearance K193440 for ER-REBOA PLUS Catheter, Substantially Equivalent on 2020-01-09. Applicant: Prytime Medical Devices, Inc..

Clearance details

Applicant: Prytime Medical Devices, Inc.
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2019-12-11
Decision date: 2020-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Boerne, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.