Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008816935

FEI Number

3009438986

Entity Name

F CARE SYSTEMS USA

City/State/Country

Miami, FL, US

Establishment Address

755 NE 164TH TERRACE, Miami, FL 33162, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

F CARE SYSTEMS USA (Owner Number: 10035152)

Owner / Operator Contact Address

11098 BISCAYNE BLVD, SUITE 301, Miami, FL 33161, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210077

PMA Number

N/A

All Registered Proprietary Names

SUPER SETON EVRF THERMAVEIN VIRIDEX KAVS MED RF 4000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBN	Catheter, Pediatric, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2023-10-26
ONQ	Electrosurgical Coagulation For Aesthetic	General, Plastic Surgery	Class 2	878.4400	2013-03-26
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2014-07-24
ONQ	Electrosurgical Coagulation For Aesthetic	General, Plastic Surgery	Class 2	878.4400	2023-05-25

Official Correspondent

PATRICK DANCIU

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

F CARE SYSTEMS USA

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
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27
K093847	Thermopeutix, Inc.	DUFLO CATHETER (HEPARIN COATED)	2010-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.

Similar Registrations

Registration Number	Establishment Name	Location
3010131137	BIOTRONIX HEALTHCARE INDUSTRIES INC.	Orlando, FL, US
3029906593	Super Seton B.V.	Amsterdam Noord-Holland, NL
2028046	NATIONAL HOSPITAL PACKAGING	City of Industry, CA, US
3031564283	VOLGO CARE INTERNATIONAL (PRIVATE) LIMITED	Sialkot Punjab, PK
3005049530	A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH	Feldkirch Vorarlberg, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008816935. Last updated year: 2026. Please use registration number 3008816935 when referencing this establishment in official correspondence.