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Shockwave Medical IVL Generator and Connector Cable
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Shockwave Medical IVL Generator and Connector Cable FDA UDI
- Generic Name
- Intravascular lithotripsy system balloon catheter, coronary FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- IVLGCCD FDA UDI
- 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. FDA UDI
Identifiers
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intravascular lithotripsy system balloon catheter, peripheralIntravascular lithotripsy system balloon catheter, coronaryIntravascular lithotripsy system generator
Shockwave Medical IVL Generator and Connector Cable by Shockwave Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular lithotripsy system generator.
Cleared under the same submission
K191840 also covers:
- Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave S4 Peripheral IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave Medical IVL Generator and Connector Cable — SHOCKWAVE MEDICAL, INC.
- Shockwave Medical IVL Generator and Connector Cable — SHOCKWAVE MEDICAL, INC.
P200039 also covers:
- Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
- Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter — SHOCKWAVE MEDICAL, INC.
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 |
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Manufacturer
- Manufacturer
- Shockwave Medical, Inc.
Sources (1)
- FDA UDI c4ada0a6-1e37-4c2a-80a3-cfd44e88902a 37 fields · synced Jun 1, 2026