pVasc Aspiration Catheter 70, 132 cm
Basic Information
- Brand Name
- pVasc Aspiration Catheter 70, 132 cm
- Primary DI
- 00851279008934
- Version / Model
- VP-AC-070-132
- Catalog Number
- VP-AC-070-132
- Company Name
- Vesalio
- Labeler DUNS
- 080986009
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-26
- Public Version
- 1
- Public Version Date
- 2026-04-03
- Public Version Status
- New
- Public Device Record Key
- d3c52cf8-43dc-4740-8c28-cc3e8f0dc577
Device Description
The pVasc® Aspiration Catheter System consists of 1) pVasc® Aspiration Catheter, 2) Peel away Introducer Sheath, and 3) an Aspiration Tubing Set. pVasc® Aspiration Catheter: The pVasc® Aspiration Catheter is a single lumen, coil-reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the peripheral vasculature when connected to a compatible aspiration pump and the Aspiration Tubing Set. The catheter is a hollow cylindrical tube constructed using a combination of medical-grade polymers with metal reinforcement, The distal end of the catheter has a hydrophilic coating aimed to reduce friction and aid tracking through the vasculature. The distal end of the catheter shaft is radiopaque for angiographic visualization. On the proximal end, the catheter incorporates a flexible strain relief, which provides kink resistance, a luer hub that allows attachment of ancillary devices for navigation, flushing and aspiration into a selected blood vessel in the peripheral vascular systems. Complete dimensions of the catheter are included on the device label. The Peel-Away Introducer is provided with the catheter to facilitate the insertion of the Peripheral Catheter’s distal tip into an appropriate vascular sheath. The pVasc® Aspiration Catheter and a Peel-Away Introducer are packaged together, they are provided sterile, non-pyrogenic, and are intended for single use only. Aspiration Tubing Set: As part of the pVasc® Aspiration Catheter System, the Vesalio® Aspiration Tubing Set is provided with a flow switch and is intended to connect the pVasc® Aspiration Catheter to a compatible aspiration pump. The Aspiration Tubing Set is intended for single use and is provided in a separate package.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | 870.5150 | 2 |
| KRA | Catheter, Continuous Flush | Cardiovascular | 870.1210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58173 | Thrombectomy suction catheter | A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851279008934 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251312 | 000 |