510(k) K260289
K260289 is an FDA 510(k) premarket notification submitted by Balosmark, Inc. for the device "Perfect-O Ostial Positioning Catheter". The FDA issued a decision of Substantially Equivalent on June 5, 2026. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2026
- Date Received
- January 29, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type