K260839
- 510(k) number
- K260839
- Device name
- Protaryx Transseptal Puncture Device (PTX2-001)
- Applicant
- Protaryx Medical, Inc. MD · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2026-04-10
- Date received
- 2026-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K260839.pdf
Official FDA record: K260839
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.