Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter
Basic Information
- Brand Name
- Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter
- Primary DI
- 00195451000096
- Version / Model
- 3.0 x 12mm
- Catalog Number
- C2IVL3012
- Company Name
- Shockwave Medical, Inc.
- Labeler DUNS
- 055514478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-17
- Public Version
- 2
- Public Version Date
- 2023-04-05
- Public Version Status
- Update
- Public Device Record Key
- 1981958b-507c-437c-bc01-52848cb5ccb0
Device Description
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
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 |
|---|---|---|---|---|
| QMG | Shockwave Intravascular Lithotripsy System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66728 | Intravascular lithotripsy system balloon catheter, coronary | An electrically-powered, flexible tube intended to be introduced into a coronary 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 | 00195451000096 | GS1 |
Customer Contacts
- Phone
- 1-877-775-4846
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200039 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Diameter | 3.0 | Millimeter | |
| Balloon Length | 12 | Millimeter | |
| Catheter Working Length | 138 | Centimeter | |
| Introducer Sheath Compatibility | 6 | French | |
| Balloon Proximal Outer Diameter (OD) | 0.045 | Inch | |
| 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