PPN · Percutaneous Catheter, Ultrasound
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | PPN |
|---|---|
| Device Name | Percutaneous Catheter, Ultrasound |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250225 | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. | Mar 25, 2025 | SESE |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | Sep 27, 2024 | SESE |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | May 7, 2024 | SESE |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | Mar 22, 2024 | SESE |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | Aug 16, 2022 | SESE |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | Apr 25, 2022 | SESE |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | Apr 22, 2021 | SESE |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Shockwave Medical, Inc. | Aug 7, 2019 | SESE |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | Shockwave Medical, Inc. | Jul 26, 2018 | SESE |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | Jun 27, 2018 | SESE |
| K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable | Shockwave Medical, Inc. | Dec 22, 2016 | SESE |
| K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable | Shockwave Medical, Inc. | Sep 14, 2016 | SESE |
Top Applicants
- Shockwave Medical, Inc. — 11 clearances
- Bolt Medical, Inc. — 1 clearance
