Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004363082

FEI Number

3004363082

Entity Name

VANGUARD-EMS

City/State/Country

BEAVERTON, OR, US

Establishment Address

3725 SW Hocken Ave, BEAVERTON, OR 97005, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Vanguard EMS, Inc. (Owner Number: 9059001)

Owner / Operator Contact Address

3725 SW Hocken Ave., --, Beaverton, OR 97005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shockwave Medical Lithoplasty System, Lithoplasty Generator and Connector Cable, Peripheral Lithoplasty Catheter Shockwave Medical Intravascular Lithotripsy (IVL) System, S4 IV Lithotripsy (IVL) Catheter, IVL Generator and Connector Shockwave Medical Lithoplasty (R) System Shockwave S4 IV Lithotripsy (IVL) Catheter, Medical Peripheral IV Lithotripsy System, IVL Generator and Connector Cable Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Shockwave Medical Peripheral Intravascular Lithotripsy, Shockwave M5 IVL Catheter, IVL Generator and Connector Cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-03-08
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-03-08
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2016-12-01
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-03-08
QMG	Shockwave Intravascular Lithotripsy System	Unknown	Class 3	N/A	2021-03-03
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-03-08

Official Correspondent

Amanda Musser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vanguard EMS, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004363082. Last updated year: 2026. Please use registration number 3004363082 when referencing this establishment in official correspondence.