| Primary Device ID | 00195451000836 |
| NIH Device Record Key | 354343d6-0013-4d5f-ad3b-aa3536daee8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shockwave CS Guide Catheter |
| Version Model Number | Shockwave CS Guide Catheter |
| Catalog Number | SWCSGC01 |
| 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 |
| 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 |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Outer Diameter | 3.1 Millimeter |
| Lumen/Inner Diameter | 2.59 Millimeter |
| Catheter Working Length | 61 Centimeter |
| Introducer Sheath Compatibilit | 9 French |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195451000836 [Primary] |
| DQY | Catheter, Percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-10 |
| Device Publish Date | 2025-06-02 |
| 00195451000836 - Shockwave CS Guide Catheter | 2025-06-10The Shockwave CS Guide Catheter is a single lumen 9F catheter consisting of a PTFE liner, stainless steel braid, and polymer outer jacket. The transition segments of the catheter have a gradual decrease in stiffness starting from the proximal shaft segment and ending at the distal tip. The Shockwave CS Guide Catheter features a pre-shaped curved distal shaft with radiopaque tip. The proximal end of the guide catheter has a standard luer fitting for connecting to a hemostasis valve. The proximal luer also includes a curve indicator to match the direction of the guide catheter tip curvature and provides a tactile and visual cue to the user. |
| 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 |
| 00195451000553 - 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 |
| 00195451000560 - 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 |
| 00195451000577 - 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 |
| 00195451000584 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripher | 2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t |