LEV-OR DILATION CATHETER OTW— 510(k) K101117

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K101117 for LEV-OR DILATION CATHETER OTW, Substantially Equivalent on 2010-07-16. Applicant: Baylis Medical Co., Inc..

Clearance details

Applicant: Baylis Medical Co., Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2010-04-21
Decision date: 2010-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

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.