CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)— 510(k) K003880

Substantially Equivalent

Concentric Medical, Inc.

FDA 510(k) clearance K003880 for CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F), Substantially Equivalent on 2001-05-16. Applicant: Concentric Medical, Inc..

Clearance details

Applicant: Concentric Medical, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2000-12-15
Decision date: 2001-05-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Moutian View, 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.