Lithoplasty® M732LPBC5060DX1

GUDID M732LPBC5060DX1

The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-enhanced balloon dilatation of otherwise difficult to treat calcified stenosis of the peripheral vasculature.

Shockwave Medical, Inc.

Ultrasound thrombolysis system catheter, peripheral
Primary Device IDM732LPBC5060DX1
NIH Device Record Key5a6e7893-ffe7-4e46-a843-7bdfa748842b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLithoplasty®
Version Model NumberM732LPBC5060DX1
Catalog NumberM732LPBC5060DX1
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 Datefalse
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
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat.
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Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM732LPBC5060DX1 [Primary]

FDA Product Code

PPNPercutaneous Catheter, Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-01-14
Device Publish Date2017-03-09

On-Brand Devices [Lithoplasty®]

M732LPBC7060DX1The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e
M732LPBC6560DX1The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e
M732LPBC6060DX1The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e
M732LPBC5560DX1The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e
M732LPBC5060DX1The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e
M732LPBC4560DX1The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e
M732LPBC4060DX1The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e
M732LPBC3560DX1The Shockwave Medical Lithoplasty® Catheter is a proprietary balloon catheter for lithotripsy-e
M732LG825D1The Shockwave Medical Inc. Lithoplasty® Generator provides power and exchanges data via a Conne
M732LCC825D1The Shockwave Medical Lithoplasty® Connector Cable is a remote actuator which connects the Lith

Trademark Results [Lithoplasty]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LITHOPLASTY
LITHOPLASTY
86303120 4671165 Live/Registered
Shockwave Medical, Inc.
2014-06-06

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