Perfect-O Ostial Positioning Catheter— 510(k) K260289

Substantially Equivalent

Balosmark, Inc.

FDA 510(k) clearance K260289 for Perfect-O Ostial Positioning Catheter, Substantially Equivalent on 2026-06-05. Applicant: Balosmark, Inc..

Clearance details

Applicant: Balosmark, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2026-01-29
Decision date: 2026-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, 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.