FDA.reportPublic FDA data

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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243757000Shockwave CS Guide CatheterShockwave Medical, Inc.2025-05-02DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195451000836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195451000836001954510008361954510008360195451000836

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA 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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length0
Introducer Sheath Compatibilit0
Lumen/Inner Diameter0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the Shockwave CS Guide Catheter in a cool, dark, dry place.

Contacts#

Phone, Email table
PhoneEmail
1-877-775-4846cs@shockwavemedical.com

Regulatory Flags#

DUNS number
055514478
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195451000003Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL2512C2PIVL25122023-08-16
00195451000010Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL3012C2PIVL30122023-08-16
00195451000027Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL3512C2PIVL35122023-08-16
00195451000034Shockwave IVL System with the Shockwave C2+ Coronary IVL CatheterC2PIVL4012C2PIVL40122023-08-16
00195451001123Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL2512C2AFIVL25122026-05-14
00195451001130Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL3012C2AFIVL30122026-05-14
00195451001147Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL3512C2AFIVL35122026-05-14
00195451001154Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL CatheterC2AFIVL4012C2AFIVL40122026-05-14
00195451000799Shockwave IVL System with the Shockwave Javelin Peripheral IVL CatheterJVNPIVLFJVNPIVLF2024-10-09
00195451000591Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL2512C2AIVL25122025-07-10
00195451000607Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL3012C2AIVL30122025-07-10
00195451000614Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL3512C2AIVL35122025-07-10
00195451000621Shockwave IVL System with the Shockwave C2 Aero Coronary IVL CatheterC2AIVL4012C2AIVL40122025-07-10
00195451000539Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL025080E8IVL0250802024-04-17
00195451000546Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL030080E8IVL0300802024-04-17
00195451000553Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL035080E8IVL0350802024-04-17
00195451000560Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL040080E8IVL0400802024-04-17
00195451000577Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL050080E8IVL0500802024-04-17
00195451000584Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterE8IVL060080E8IVL0600802024-04-17
00195451000386Shockwave IVL System with the Shockwave L6 Peripheral IVL CatheterL6IVL080030L6IVL0800302022-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
00191506019563Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019587Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019600Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019624Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019648Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019662Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019686Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019709Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019723Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019747Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019761Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019785Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019808Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019822Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019846Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019860Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019884Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16