DEVICE: Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable (00195451000294)
Device Identifier (DI) Information
Shockwave Intravascular Lithotripsy (IVL) Generator and Connector Cable
825D
In Commercial Distribution
IVLGCCD
Shockwave Medical, Inc.
825D
In Commercial Distribution
IVLGCCD
Shockwave Medical, Inc.
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
| Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
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Active | false |
| 66729 | Intravascular lithotripsy system balloon catheter, peripheral |
An electrically-powered, flexible tube intended to be introduced into a peripheral 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.
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Active | false |
| 66730 | Intravascular lithotripsy system generator |
An electrically-powered device intended to produce electrical current for transmission to an appropriate catheter (not included) to perform intravascular lithotripsy in peripheral and/or coronary arteries. It typically includes controls, display, and connection cables. This is a reusable device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| PPN | Percutaneous Catheter, Ultrasound |
| QMG | Shockwave Intravascular Lithotripsy System |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K191840 | 000 |
| P200039 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 10 and 35 Degrees Celsius |
| Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c4ada0a6-1e37-4c2a-80a3-cfd44e88902a
April 05, 2023
4
February 11, 2021
April 05, 2023
4
February 11, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-877-775-4846
cs@shockwavemedical.com
cs@shockwavemedical.com