Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary C2PIVL2512

GUDID 00195451000003

The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.

Shockwave Medical, Inc.

Intravascular lithotripsy system balloon catheter, coronary
Primary Device ID00195451000003
NIH Device Record Keyd8dea4cf-0ca8-42c7-b801-5c9afdc77612
Commercial Distribution StatusIn Commercial Distribution
Brand NameShockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary
Version Model Number2.5x12mm
Catalog NumberC2PIVL2512
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Device Dimensions

Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French
Balloon Length12 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Proximal Outer Diamete0.044 Inch
Length138 Centimeter
Guidewire Compatibility5 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight, Keep dry, P401 - store at.. a cool, dark, and dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100195451000003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QMGShockwave Intravascular Lithotripsy System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-24
Device Publish Date2023-08-16

On-Brand Devices [Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary]

00195451000034The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through th
00195451000027The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through th
00195451000010The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through th
00195451000003The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through th
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