Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015489145

FEI Number

3015489145

Entity Name

THROMBOLEX, INC.

City/State/Country

New Britain, PA, US

Establishment Address

75 Britain Dr., New Britain, PA 18901, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Thrombolex, Inc. (Owner Number: 10059988)

Owner / Operator Contact Address

75 Britain Dr., New Britain, PA 18901, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222095

PMA Number

N/A

All Registered Proprietary Names

BASHIR Plus Endovascular Catheter BASHIR Endovascular Catheter BASHIR Endovascular Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-02-04
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2020-02-04
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2019-03-18
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-03-18
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2023-06-02
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2023-06-02

Official Correspondent

Amy Katsikis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Thrombolex, Inc.

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
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08

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3026567963	ENDOVASCULAR ENGINEERING, INC.	Menlo Park, CA, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3019525998	VASCUPATENT MEDICAL (SHENZHEN) CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015489145. Last updated year: 2026. Please use registration number 3015489145 when referencing this establishment in official correspondence.