Protaryx Transseptal Puncture Device (PTX2-001)
Device Facts
| Record ID | K260839 |
|---|---|
| Device Name | Protaryx Transseptal Puncture Device (PTX2-001) |
| Applicant | Protaryx Medical, Inc. |
| Product Code | DYB · Cardiovascular |
| Decision Date | Apr 10, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
