510(k) K260839
K260839 is an FDA 510(k) premarket notification submitted by Protaryx Medical, Inc. for the device "Protaryx Transseptal Puncture Device (PTX2-001)". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2026
- Date Received
- March 13, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type