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

Name: FDA 510(k) clearance K062275
Creator: U.S. Food and Drug Administration
Published: 2006-09-20

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.. Device class: 2.

Clearance details

Applicant: Kerberos Proximal Solutions, Inc.
Product code: Code QEZ
Device class: Class 2
Regulation: 21 CFR 870.5150
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 ↗

Recent devices under product code QEZ

view all

K254035 — Mayumi Thrombectomy System2026-09-03
K261105 — Powered Aventus Thrombectomy System2026-07-27
K262030 — Aventus Thrombectomy System2026-07-15
K253589 — Liberant RX Aspiration Catheter2026-04-23
K254208 — FLOWRUNNER Aspiration System2026-03-20

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.

Clearance details

Recent devices under product code QEZ

More clearances from Kerberos Proximal Solutions, Inc.

Adverse events under product code QEZ