Protaryx Transseptal Puncture Device (PTX2-001)— 510(k) K260839

Name: FDA 510(k) clearance K260839
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Substantially Equivalent

Protaryx 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 filed under DYB, catheter introducers. The record doesn't describe its design.

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), and the record flags it as a third-party review.

Clearance details

Applicant: Protaryx Medical, Inc.
Product code: Product code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2026-03-13
Decision date: 2026-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse 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, 2020-01-01 through 2026-04-23. 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.