Lithoplasty® M732LPBC5560DX1
GUDID M732LPBC5560DX1
The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilation of otherwise difficult to treat calcified stenosis of the peripheral vasculature.
Shockwave Medical, Inc.
Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral| Primary Device ID | M732LPBC5560DX1 |
| NIH Device Record Key | 9c4398bb-51ef-4818-a5fa-c40baa3ab5c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lithoplasty® |
| Version Model Number | M732LPBC5560DX1 |
| Catalog Number | M732LPBC5560DX1 |
| Company DUNS | 055514478 |
| Company Name | Shockwave Medical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com |
Device Dimensions
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and keep away from heat. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M732LPBC5560DX1 [Primary] |
FDA Product Code
| PPN | Percutaneous Catheter, Ultrasound |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-01-14 |
| Device Publish Date | 2017-03-09 |
On-Brand Devices [Lithoplasty®]
| M732LPBC7060DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
| M732LPBC6560DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
| M732LPBC6060DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
| M732LPBC5560DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
| M732LPBC5060DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
| M732LPBC4560DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
| M732LPBC4060DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
| M732LPBC3560DX1 | The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e |
| M732LG825D1 | The Shockwave Medical Inc. Lithoplasty® Generator provides power and exchanges data via a Conne |
| M732LCC825D1 | The Shockwave Medical Lithoplasty® Connector Cable is a remote actuator which connects the Lith |
Trademark Results [Lithoplasty]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LITHOPLASTY 86303120 4671165 Live/Registered |
Shockwave Medical, Inc. 2014-06-06 |
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