Protaryx Medical, Inc. · Class II · Cleared Apr 10, 2026
| K-number | K260839 |
| Device name | Protaryx Transseptal Puncture Device (PTX2-001) |
| Applicant | Protaryx Medical, Inc. |
| Product code | DYB |
| Device class | Class II |
| Decision date | Apr 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
The Protaryx Transseptal Puncture Device (PTX2-001) is a sterile, single-use introducer catheter comprising a sheath, dilator, and pigtail guidewire. It is used to introduce cardiovascular catheters to the heart, including the left side, by enabling left heart access through puncture of the atrial septum during transseptal catheterization procedures performed by electrophysiologists and interventional cardiologists.
The device combines features of multiple predicate devices into a single unit and uses an RF (radiofrequency) guidewire as the means of access. Materials, technological aspects, packaging, and sterilization are similar to predicates. Design and technological differences do not raise different safety or effectiveness questions.
ISO 10555-1 (catheter requirements), ISO 10993-1:2009/Cor.1:2010 (biological evaluation), ISO 11135-1:2014 (sterilization validation), ISO 10993-7:2008/Cor.1:2009 (sterilization residual limits), and ANSI/AAMI/ISO 11607:2006 (packaging validation). LAL pyrogen testing per FDA and USP specifications was also conducted.
View the full FDA submission: accessdata.fda.gov