Shockwave Intravascular Lithotripsy (IVL) Connector Cable IVLCC

GUDID 00195451000300

The Shockwave Medical Intravascular Lithotripsy (IVL) Connector Cable is a remote actuator which connects the IVL Generator to the IVL Catheter and is used to activate lithotripsy energy within the IVL balloon catheter.

Shockwave Medical, Inc.

Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Ultrasonic lithotripsy system transducer, single-use Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch Electrical catheter connection cable/switch
Primary Device ID00195451000300
NIH Device Record Key421d8bdf-9e78-47c3-b2b9-fb74f6e34e50
Commercial Distribution StatusIn Commercial Distribution
Brand NameShockwave Intravascular Lithotripsy (IVL) Connector Cable
Version Model Number825D
Catalog NumberIVLCC
Company DUNS055514478
Company NameShockwave Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100195451000300 [Primary]
HIBCCM732IVLCC0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PPNPercutaneous Catheter, Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-19
Device Publish Date2021-02-11

Devices Manufactured by Shockwave Medical, Inc.

00195451000539 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Periphera2024-04-25 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 Periphera2024-04-25 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 Periphera2024-04-25 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 Periphera2024-04-25 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 Periphera2024-04-25 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 Peripher2024-04-25 The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities t
00195451000003 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary2023-08-24 The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of th
00195451000010 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary2023-08-24 The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of th
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