Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005173255

FEI Number

3005173255

Entity Name

Viant Costa Rica, S.A.

City/State/Country

BARREAL DE HEREDIA, CR

Establishment Address

Parque Zona Franca Metropolitana, Edificio 2C, BARREAL DE HEREDIA --, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Viant Medical, LLC (Owner Number: 9043339)

Owner / Operator Contact Address

2 Hampshire Street, Suite 202, Foxborough, MA 02035, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neptune E-SEP 125mm blade electrode coated Neptune E-SEP 125mm blade electrode Neptune E-SEP 165mm blade electrode Neptune E-SEP loop t-bar electrode W20 D20 L120 Neptune E-SEP conization electrode W16 D18 L120 Neptune E-SEP loop ubar electrode W20 D20 L120 Neptune E-SEP conization electrode W13 D15 L120 Neptune E-SEP loop t-bar electrode W10 D10 L120 Neptune E-SEP 3mm ball electrode Neptune E-SEP conization electrode W20 D20 L120 Neptune E-SEP loop t-bar electrode W15 D12 L120 Neptune E-SEP loop t-bar electrode W20 D15 L120 Neptune E-SEP 70mm Needle Electrode Neptune E-SEP loop t-bar electrode W20 D20 L60 Neptune E-SEP 70mm Blade Electrode Neptune E-SEP 165mm blade electrode coated Neptune E-SEP 5mm ball electrode Neptune E-SEP 70mm Blade electrode coated Neptune E-SEP conization electrode W13 D20 L120 Neptune E-SEP loop t-bar electrode W20 D15 L60 Neptune E-SEP conization electrode W16 D8 L120 LENSAR Sterile Drape Sub-Assembly, Cannula, RCSP, Silicone, w/ Manual Inflating Elongated Smooth Cuff, Guidewire Style Stylet, 15 FR Sub-Assembly, Cannula, RCSP, Silicone, with Manual Inflating MR20 Ridged Cuff, Guidewire Style Stylet, 15 FR Sub-Assembly, Cannula, RCSP, Silicone, w/ Manual Inflating Ridged Cuff, Guidewire Stylet, Tru-touch Handle, 15FR Sub-Assembly, Cannula, RCSP, Silicone, with Manual Inflating Elongated Smooth Cuff, Solid Stylet, 15 FR Sub-Assembly, Cannula, RCSP, Silicone, w/ Manual Inflating MR20 Ridged Cuff, Ext Press Monitoring & Inflation Lines, 13 Sub-Assembly, Cannula, RCSP, Gundry, Silicone, w/ Manual Inflating MR20 Ridged Cuff, Guidewire Stylet,13 FR Sub-Assembly, Cannula, RCSP, Silicone, w/ Manual Inflating Ridged Cuff, Solid Stylet, Tru-touch Handle, 15FR LENSAR Laser System FS-3D Zimmer ATS Hose Adapters (Red and Blue) Zimmer ATS Single Hose w/CPC Connectors Zimmer ATS 1500/2000/3000/4000TS Dual Hose Assembly (Blue/White and Red/White) Zimmer ATS HOSE ASSEMBLY BLU Zimmer ATS DUAL HOSE W/CPC CONNECTORS Zimmer ATS 500/750/1200/2200TS Hose Assembly Red Neptune SafeAir 70mm Suction Sleeve Neptune SafeAir 125mm Needle Electrode Neptune ® E-SEP TM 125mm Blade Electrode, Coated and Insulated Neptune SafeAir 70mm Blade Electrode, Coated and Insulated, 2mm Exposed Neptune SafeAir 65mm Suction Sleeve Neptune ® E-SEP TM 70mm Blade Electrode, Coated and Insulated Neptune ® E-SEP TM 165mm Blade Electrode, Coated and Insulated Neptune SafeAir 70mm Squared Blade Electrode Coated Apollo RF Aspirating Ablator, Extra Large Apollo RF Aspirating Ablator, Multi-Port Apollo RF MP50, Aspirating Ablator 50, Multi-Port Venclose Maven Catheter Neptune E-SEP 125MM Suction Sleeve Neptune E-SEP 165MM Suction Sleeve Zimmer LG ORIFIC TIP W/SHIELD HI-CAP Zimmer 6 ORIFICE SHOWER TIP HI-CAP Zimmer 12IN INTRAMED TIP HI-CAP Zimmer HG CAP SHOWER SPRAY 10 Zimmer PULS HIGH CAP IM TIP Zimmer PULS HIGH CAP FAN TIP Zimmer TIBIAL PLATEAU BRSH TIP HI-CAP Zimmer DUAL SPIKE Y-CONN. SET PKGD Zimmer PULS HIGH CAP BRUSH TIP 10/BOX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-20
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2022-07-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-08-13
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2017-10-31
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2020-11-13
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2017-10-18
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2017-09-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-06-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-04-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-08-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-08-10
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2018-08-02

Official Correspondent

David Rose

US Agent Details

David Rose Email: david.rose@viantmedical.com Phone: (480) 5536400

Related Public Records

Same Entity

Viant Medical, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2954750	Viant Fremont, Inc	FREMONT, CA, US
2244012	Viant Medical, Inc	S Plainfield, NJ, US
3006194679	Viant Medical SUZHOU EPZ Co., Ltd	JIANGSU PROVINCE, CN
3009493875	Viant Medical, Inc.	Grand Rapids, MI, US
1832228	Viant AS&O Holdings, LLC	Indianapolis, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-1515-2015	Abbott Medical Optics, Inc.	2	OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

Similar Registrations

Registration Number	Establishment Name	Location
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3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005173255. Last updated year: 2026. Please use registration number 3005173255 when referencing this establishment in official correspondence.