Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter
- Primary DI
- 00195451000072
- Version / Model
- S4IVL4040
- Catalog Number
- S4IVL4040
- Company Name
- Shockwave Medical, Inc.
- Labeler DUNS
- 055514478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-04
- Public Version
- 6
- Public Version Date
- 2025-12-25
- Public Version Status
- Update
- Public Device Record Key
- c0af6d05-01b9-4d14-af37-39569875fa4d
Device Description
The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| PPN | Percutaneous Catheter, Ultrasound | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66729 | Intravascular lithotripsy system catheter, balloon, peripheral | An electrically-powered, flexible tube, with an inflatable balloon at its distal end, intended to be introduced into a peripheral artery (excludes coronary and cerebral arteries) to transmit ultrasonic acoustic pressure waves circumferentially for the modification and fragmentation of calcified plaque, to improve vessel compliance. It includes transducers intended to convert electrical to ultrasonic energy, and a balloon to facilitate energy transmission and vessel dilation. It is used in conjunction with a dedicated control unit/generator (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195451000072 | GS1 | ||||
| Previous | M732S4IVL40400 | HIBCC |
Customer Contacts
- Phone
- 1-877-775-4846
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191840 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Working Length | 135 | Centimeter | |
| Balloon Proximal Outer Diameter (OD) | 0.054 | Inch | |
| Balloon Diameter | 4.0 | Millimeter | |
| Balloon Length | 40 | Millimeter | |
| Introducer Sheath Compatibility | 5 | French | |
| Guidewire Diameter | 0.014 | Inch | |
| Balloon Nominal (Inflation) Pressure | 6 | Atmosphere | |
| Balloon Rated Burst Pressure | 10 | Atmosphere |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and keep away from heat