Shockwave CS Guide Catheter
- Primary DI
- 00195451000836
- Brand
- Shockwave CS Guide Catheter
- Company
- Shockwave Medical, Inc.
- Model
- Shockwave CS Guide Catheter
- Catalog number
- SWCSGC01
- Device description
- The 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.
- Published
- 2025-06-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
shockwavemedical.comProduct Codes#
| Code | Name |
|---|---|
| DQY | Catheter, Percutaneous |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K243757 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00195451000836 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00195451000836 | 00195451000836 | 195451000836 | 0195451000836 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Working Length | 61 | Centimeter |
| Introducer Sheath Compatibilit | 9 | French |
| Lumen/Inner Diameter | 2.59 | Millimeter |
| Outer Diameter | 3.1 | Millimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Store the Shockwave CS Guide Catheter in a cool, dark, dry place. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 1-877-775-4846 | cs@shockwavemedical.com |
Regulatory Flags#
- DUNS number
- 055514478
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00195451000003 | Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter | C2PIVL2512 | C2PIVL2512 | 2023-08-16 |
| 00195451000010 | Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter | C2PIVL3012 | C2PIVL3012 | 2023-08-16 |
| 00195451000027 | Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter | C2PIVL3512 | C2PIVL3512 | 2023-08-16 |
| 00195451000034 | Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter | C2PIVL4012 | C2PIVL4012 | 2023-08-16 |
| 00195451001123 | Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter | C2AFIVL2512 | C2AFIVL2512 | 2026-05-14 |
| 00195451001130 | Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter | C2AFIVL3012 | C2AFIVL3012 | 2026-05-14 |
| 00195451001147 | Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter | C2AFIVL3512 | C2AFIVL3512 | 2026-05-14 |
| 00195451001154 | Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter | C2AFIVL4012 | C2AFIVL4012 | 2026-05-14 |
| 00195451000799 | Shockwave IVL System with the Shockwave Javelin Peripheral IVL Catheter | JVNPIVLF | JVNPIVLF | 2024-10-09 |
| 00195451000591 | Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter | C2AIVL2512 | C2AIVL2512 | 2025-07-10 |
| 00195451000607 | Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter | C2AIVL3012 | C2AIVL3012 | 2025-07-10 |
| 00195451000614 | Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter | C2AIVL3512 | C2AIVL3512 | 2025-07-10 |
| 00195451000621 | Shockwave IVL System with the Shockwave C2 Aero Coronary IVL Catheter | C2AIVL4012 | C2AIVL4012 | 2025-07-10 |
| 00195451000539 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | E8IVL025080 | E8IVL025080 | 2024-04-17 |
| 00195451000546 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | E8IVL030080 | E8IVL030080 | 2024-04-17 |
| 00195451000553 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | E8IVL035080 | E8IVL035080 | 2024-04-17 |
| 00195451000560 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | E8IVL040080 | E8IVL040080 | 2024-04-17 |
| 00195451000577 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | E8IVL050080 | E8IVL050080 | 2024-04-17 |
| 00195451000584 | Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter | E8IVL060080 | E8IVL060080 | 2024-04-17 |
| 00195451000386 | Shockwave IVL System with the Shockwave L6 Peripheral IVL Catheter | L6IVL080030 | L6IVL080030 | 2022-10-24 |
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