K260839
Substantially EquivalentProtaryx Transseptal Puncture Device (PTX2-001)
The Protaryx Transseptal Puncture Device (PTX2-001) is a specialized cardiology access tool — product code DYB covers transseptal needles used to cross from the right atrium to the left atrium through the interatrial septum during electrophysiology and structural-heart procedures. It's a narrow-indication device used mainly in atrial fibrillation ablation and left atrial appendage occlusion cases.
Cardiovascular panel, Traditional 510(k). DYB sees low filing volume because the addressable market is concentrated in a handful of players (Medtronic, Baylis/Boston Scientific). A new entrant on this code typically signals a device with specific technical differentiation — steerability, visualization, or radiofrequency-assisted crossing.
Protaryx Medical, Inc. files from Baltimore, MD. Less than a month from filing (March 13, 2026) to decision (April 10, 2026) — unusually fast and likely means the application was a clean substantial-equivalence match or had been pre-submitted for Q-Sub discussions before formal filing.
- Applicant
- Protaryx Medical, Inc.
- Product code
- DYB
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
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, 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.