Protaryx Transseptal Puncture Device (PTX2-001)— 510(k) K260839
Substantially EquivalentProtaryx Medical, Inc.
FDA 510(k) clearance K260839 for Protaryx Transseptal Puncture Device (PTX2-001), Substantially Equivalent on 2026-04-10. Applicant: Protaryx Medical, Inc.. Device class: 2.
Summary
The Protaryx Transseptal Puncture Device (PTX2-001) is for crossing the interatrial septum from the right atrium to the left, the access step for procedures like left atrial ablation and appendage occlusion. It's filed under DYB, catheter introducers.
Class II, 21 CFR 870.1340. The Cardiovascular panel reviewed it as a Traditional 510(k).
Protaryx Medical filed from Baltimore, Maryland. The review took 28 days (March 13 to April 10, 2026). A Traditional 510(k) that clears in four weeks generally means FDA had no questions.
Clearance details
- Applicant
- Protaryx Medical, Inc.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
Recent devices under product code DYB
view allAdverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
Source: openFDA MAUDE database, through . 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.