Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027545377

FEI Number

3027545377

Entity Name

SWAV CR SRL

City/State/Country

Alajuela, CR

Establishment Address

Coyol Free Zone, Building B50.B., El Coyol, Alajuela 20101, CR

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Shockwave Medical, Inc. (Owner Number: 10046972)

Owner / Operator Contact Address

5403 Betsy Ross Drive, Santa Clara, CA 95054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P200039

All Registered Proprietary Names

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter Shockwave C2+ Shockwave C2 Aero Fly Coronary IVL Catheter Shockwave C2 Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary IVL Catheter Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter Shockwave C2 Catheter Shockwave C2 Aero Coronary IVL Catheter Shockwave Intravascular Lithotripsy System with Shockwave C2+ Coronary IVL Catheter Shockwave C2+ Coronary IVL Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2024-04-02
QMG	Shockwave Intravascular Lithotripsy System	Unknown	Class 3	N/A	2021-02-16

Official Correspondent

Peter Nowakowski

US Agent Details

Peter Nowakowski Business: SHOCKWAVE MEDICAL, INC. Email: pnowakowski@shockwavemedical.com Phone: (408) 5502609

Related Public Records

Same Entity

Shockwave Medical, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015053858	SHOCKWAVE MEDICAL, INC.	Santa Clara, CA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027545377. Last updated year: 2026. Please use registration number 3027545377 when referencing this establishment in official correspondence.