| Primary Device ID | M732IVLCC0 |
| NIH Device Record Key | a805d129-8e95-4794-bf48-d5cadd373b67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intravascular Lithotripsy (IVL) Connector Cable |
| Version Model Number | 825DP |
| Catalog Number | IVLCC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
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| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M732IVLCC0 [Primary] |
| PPN | Percutaneous Catheter, Ultrasound |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-01-14 |
| Device Publish Date | 2018-12-14 |
| 00195451000591 - Shockwave C2 Aero Coronary IVL Catheter | 2025-07-18 The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system o |
| 00195451000607 - Shockwave C2 Aero Coronary IVL Catheter | 2025-07-18 The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system o |
| 00195451000614 - Shockwave C2 Aero Coronary IVL Catheter | 2025-07-18 The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system o |
| 00195451000621 - Shockwave C2 Aero Coronary IVL Catheter | 2025-07-18 The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system o |
| 00195451000836 - Shockwave CS Guide Catheter | 2025-06-10 The Shockwave CS Guide Catheter is a single lumen 9F catheter consisting of a PTFE liner, stainless steel braid, and polymer out |
| 00195451000799 - Javelin Peripheral IVL Catheter | 2024-10-17 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t |
| 00195451000539 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera | 2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t |
| 00195451000546 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera | 2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t |