Identity
- Trade Name
- Lithoplasty® FDA UDI
- Generic Name
- Ultrasound thrombolysis system catheter, peripheral FDA UDI
- Device Name
- The Shockwave Medical Lithoplasty® Connector Cable is a remote actuator which connects the Lithoplasty® Generator to the Lithoplasty® Catheter and is used to activate lithotripsy energy within the balloon. FDA UDI
- Model / Reference
- M732LCC825D1 FDA UDI
- Description
- The Shockwave Medical Lithoplasty® Connector Cable is a remote actuator which connects the Lithoplasty® Generator to the Lithoplasty® Catheter and is used to activate lithotripsy energy within the balloon. FDA UDI
Identifiers
- Catalog Number
- M732LCC825D1 FDA UDI
- Primary DI / UDI-DI
- M732LCC825D1 FDA UDI
- FDA Product Code
- PPN FDA UDIQMG FDA UDI
- GMDN Term
- Ultrasound thrombolysis system catheter, peripheral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Lithoplasty® by Shockwave Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shockwave Medical, Inc.
Sources (1)
- FDA UDI 63b5a345-4e86-4fdc-94e0-7167a55ce1c8 36 fields · synced Jun 1, 2026