K260289
- 510(k) number
- K260289
- Device name
- Perfect-O Ostial Positioning Catheter
- Applicant
- Balosmark, Inc. MI · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2026-06-05
- Date received
- 2026-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260289.pdf
Official FDA record: K260289
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.