CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES— 510(k) K060927

Substantially Equivalent

Ceres Medical Systems, LLC

FDA 510(k) clearance K060927 for CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES, Substantially Equivalent on 2006-10-06. Applicant: Ceres Medical Systems, LLC.

Clearance details

Applicant: Ceres Medical Systems, LLC
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2006-04-04
Decision date: 2006-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.