RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135— 510(k) K062275

Unknown

Kerberos Proximal Solutions, Inc.

FDA 510(k) clearance K062275 for RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135, Unknown on 2006-09-20. Applicant: Kerberos Proximal Solutions, Inc..

Clearance details

Applicant: Kerberos Proximal Solutions, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2006-08-07
Decision date: 2006-09-20
Decision: Unknown
Clearance type: Special
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.