FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Shockwave M5
DI: M732M5IVL35600
·
Model: 3.5mm x 60mm
·
Shockwave Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Shockwave M5
- Primary DI
- M732M5IVL35600
- Version / Model
- 3.5mm x 60mm
- Catalog Number
- M5IVL3560
- Company Name
- Shockwave Medical, Inc.
- Labeler DUNS
- 055514478
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-17
- Public Version
- 4
- Public Version Date
- 2021-04-21
- Public Version Status
- Update
- Public Device Record Key
- bf651b0a-ffd6-45e0-8edc-be1d955ed11f
- Distribution End Date
- 2020-12-16
Device Description
The Shockwave M5 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 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 |
|---|---|---|---|---|
| 59026 | Ultrasound thrombolysis system catheter, peripheral | A flexible tube designed for the percutaneous intravascular administration of high-frequency, low-energy ultrasound and drugs [e.g., tissue plasminogen activator (tPA)] for the disruption of clotted blood (i.e., a thrombus or thromboembolus) in a peripheral artery. It typically consists of a side-hole drug infusion catheter with a multi-element ultrasound core wire. The ultrasound is intended to prepare the clot by unwinding the fibrin strands, therefore enabling increased drug permeation through the clot to the vessel wall. It is a component of a system that includes a control unit to deliver the ultrasound. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M732M5IVL35600 | HIBCC |
Customer Contacts
- Phone
- 1-877-775-4846
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Introducer Sheath Compatibility | 6 | French | |
| Catheter Working Length | 110 | Centimeter | |
| Balloon Proximal Outer Diameter (OD) | 0.064 | Inch | |
| Balloon Length | 60 | Millimeter | |
| Balloon Rated Burst Pressure | 10 | Atmosphere | |
| Balloon Nominal (Inflation) Pressure | 6 | Atmosphere | |
| Guidewire Diameter | 0.014 | Inch | |
| Balloon Diameter | 3.5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and keep away from heat