Percutaneous Catheter, Ultrasound
The Percutaneous Catheter, Ultrasound is a cardiovascular catheter intended for ultrasound wave-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature. It is classified as FDA Class 2 under 21 CFR 870.1250, requiring a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The device is used in the Cardiovascular specialty to treat peripheral arterial disease through a minimally invasive approach. Product code PPN; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PPN
- Device Class
- FDA class 2
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250225 | Bolt Intravascular Lithotripsy (IVL) System | Mar 25, 2025 | Substantially Equivalent | Bolt Medical, Inc. |
| K242213 | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Sep 27, 2024 | Substantially Equivalent | Shockwave Medical, Inc. |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | May 07, 2024 | Substantially Equivalent | Shockwave Medical, Inc. |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Mar 22, 2024 | Substantially Equivalent | Shockwave Medical, Inc. |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Aug 16, 2022 | Substantially Equivalent | Shockwave Medical, Inc. |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Apr 25, 2022 | Substantially Equivalent | Shockwave Medical, Inc. |
| K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Apr 22, 2021 | Substantially Equivalent | Shockwave Medical, Inc. |
| K191840 | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Aug 07, 2019 | Substantially Equivalent | Shockwave Medical, Inc. |
| K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | Jul 26, 2018 | Substantially Equivalent | Shockwave Medical, Inc. |
| K180454 | Shockwave Medical Intravascular Lithotripsy (IVL) System | Jun 27, 2018 | Substantially Equivalent | Shockwave Medical, Inc. |
| K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable | Dec 22, 2016 | Substantially Equivalent | Shockwave Medical, Inc. |
| K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable | Sep 14, 2016 | Substantially Equivalent | Shockwave Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.