FDA UDI
In Commercial Distribution
🇺🇸 United States
Shockwave S4
DI: 00195451000041
·
Model: 2.5 x 40mm
·
Shockwave Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Shockwave S4
- Primary DI
- 00195451000041
- Version / Model
- 2.5 x 40mm
- Catalog Number
- S4IVL2540
- 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
- 4
- Public Version Date
- 2023-04-05
- Public Version Status
- Update
- Public Device Record Key
- fe990cd1-0e99-4d45-8ea2-9d227260e564
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 balloon catheter, peripheral | An electrically-powered, flexible tube intended to be introduced into a peripheral artery stiffened by a highly calcified atheromatous plaque, to transmit ultrasound (US) waves [e.g., acoustic pressure pulses] for the disruption of the plaque to improve vessel compliance. It is used in conjunction with a dedicated control unit/generator (not included) and includes transducers intended to convert electrical energy to ultrasound and an inflatable balloon at its distal end to facilitate energy transmission and dilation of the vessel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195451000041 | GS1 | ||||
| Previous | M732S4IVL25400 | HIBCC |
Customer Contacts
- Phone
- 1-877-775-4846
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191840 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Rated Burst Pressure | 10 | Atmosphere | |
| Balloon Nominal (Inflation) Pressure | 6 | Atmosphere | |
| Guidewire Diameter | 0.014 | Inch | |
| Introducer Sheath Compatibility | 5 | French | |
| Balloon Length | 40 | Millimeter | |
| Balloon Diameter | 2.5 | Millimeter | |
| Balloon Proximal Outer Diameter (OD) | 0.052 | Inch | |
| Catheter Working Length | 135 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and keep away from heat