Lithoplasty® M732LPBC5060DX1
GUDID M732LPBC5060DX1
The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilatation of otherwise difficult to treat calcified stenosis of the peripheral vasculature.
Shockwave Medical, Inc.
Ultrasound thrombolysis system catheter, peripheral| Primary Device ID | M732LPBC5060DX1 |
| NIH Device Record Key | 5a6e7893-ffe7-4e46-a843-7bdfa748842b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lithoplasty® |
| Version Model Number | M732LPBC5060DX1 |
| Catalog Number | M732LPBC5060DX1 |
| 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 | M732LPBC5060DX1 [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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