FDA UDI
In Commercial Distribution
🇺🇸 United States
Shockwave Intravascular Lithotripsy (IVL) Connector Cable
DI: 00195451000300
·
Model: 825DP
·
Shockwave Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Shockwave Intravascular Lithotripsy (IVL) Connector Cable
- Primary DI
- 00195451000300
- Version / Model
- 825DP
- Catalog Number
- IVLCC
- Company Name
- Shockwave Medical, Inc.
- Labeler DUNS
- 055514478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-11
- Public Version
- 4
- Public Version Date
- 2023-04-05
- Public Version Status
- Update
- Public Device Record Key
- 421d8bdf-9e78-47c3-b2b9-fb74f6e34e50
Device Description
The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter.
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 |
|---|---|---|---|---|
| 66727 | Electrical catheter connection cable/switch | A non-patient-contact, electrical cord with a connector at both ends and a hand-switch designed to transmit electrical energy from a power supply (e.g., generator) to an electrical catheter (e.g., ultrasonic atherectomy system catheter), and activate/deactivate the electrical supply to the catheter; the power supply and catheter are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195451000300 | GS1 | ||||
| Previous | M732IVLCC0 | HIBCC |
Customer Contacts
- Phone
- 1-877-775-4846
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191840 | 000 |
| P200039 | 000 |