Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008439199

FEI Number

3008439199

Entity Name

STRAUB MEDICAL AG

City/State/Country

Wangs Sankt Gallen, CH

Establishment Address

Straubstrasse 12, Wangs Sankt Gallen 7323, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Straub Medical AG (Owner Number: 10061638)

Owner / Operator Contact Address

850 W Rio Salado Parkway, Suite 100, Tempe, AZ 85281, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172315

PMA Number

N/A

All Registered Proprietary Names

Rotarex S Straub Endovascular System Rotarex Atherectomy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2019-11-18
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-11-18

Official Correspondent

Kristen Ortiz

US Agent Details

Kristen Ortiz Email: kristen.ortiz@bd.com Phone: (602) 8305652

Related Public Records

Same Entity

Straub Medical AG

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241362	Surmodics,Inc.	Pounce XL Thrombectomy System (PTS-1011-7F135)	2024-09-11
K220887	Inari Medical	Mini-ClotTriever Thrombectomy System	2022-08-04
K250421	Inari Medical, Inc.	InThrill Thrombectomy System	2025-05-12
K192036	Inari Medical	ClotTriever Thrombectomy System	2019-08-29

Similar Registrations

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3015924373	AUSA Medical Device Pvt Ltd	Bangalore Karnataka, IN
3017823876	Expanse Medical Inc.	Pleasanton, CA, US
3015615738	Penumbra Inc.	Salt Lake City, UT, US
3029444898	ICHOR VASCULAR INC	Brecksville, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008439199. Last updated year: 2026. Please use registration number 3008439199 when referencing this establishment in official correspondence.