FDA UDI
In Commercial Distribution
🇺🇸 United States
Shockwave Medical IVL Generator and Connector Cable
DI: M732IVLGCC0
·
Model: IVLGCC
·
Shockwave Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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 Medical IVL Generator and Connector Cable
- Primary DI
- M732IVLGCC0
- Version / Model
- IVLGCC
- Catalog Number
- IVLGCC
- Company Name
- Shockwave Medical, Inc.
- Labeler DUNS
- 055514478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-14
- Public Version
- 6
- Public Version Date
- 2025-08-29
- Public Version Status
- Update
- Public Device Record Key
- 1c549de5-53d5-43c3-9ca3-2e81887821ac
Device Description
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PPN | Percutaneous Catheter, Ultrasound | Cardiovascular | 870.1250 | 2 |
| QMG | Shockwave Intravascular Lithotripsy System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59025 | Ultrasound thrombolysis system control unit | An electrically-powered device designed to generate high-frequency, low-energy ultrasound for intravascular administration to help disrupt clotted blood (i.e., a thrombus or thromboembolus). It is designed to be used with a dedicated infusion catheter for thrombolytic drug administration. 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 typically consists of a user interface, piezoelectric transducer, and one or more rechargeable battery for independent/mobile use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M732IVLGCC0 | HIBCC |
Customer Contacts
- Phone
- 1-877-775-4846
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius