Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017987980

FEI Number

3017987980

Entity Name

Terumo Cardiovascular Costa Rica LLC

City/State/Country

Zona Franca La Lima Cartago, CR

Establishment Address

Calle 58, Zona Franca La Lima Cartago 30106, CR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Terumo Cardiovascular Systems Corp. (Owner Number: 10039199)

Owner / Operator Contact Address

6200 Jackson Road, Ann Arbor, MI 48103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K013578

PMA Number

N/A

All Registered Proprietary Names

Cardiovascular Procedure Kit Pump Tubing Breathing circuit filter Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass HEAT-EXCHANGER CPB Check Valve Breathing Circuit Pump Tubing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2021-11-16
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2023-05-23
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-05-23
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2023-05-23
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2023-05-23
MJJ	Cpb Check Valve, Retrograde Flow, In-Line	Cardiovascular	Class 2	870.4400	2023-05-23
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2023-05-23
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2023-05-23

Official Correspondent

Lisa Hessabi

US Agent Details

Lisa Hessabi Business: Terumo Cardiovascular Systems Corp. Email: lisa.hessabi@terumomedical.com Phone: (734) 7416324

Related Public Records

Same Entity

Terumo Cardiovascular Systems Corp.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1828100	TERUMO CARDIOVASCULAR SYSTEMS CORPORATION	ANN ARBOR, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233702	LivaNova USA, Inc.	SMARxT Tubing and Connectors	2024-08-08
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2011	Maquet Inc.	2	MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400

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1047429	AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305	TOANO, VA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017987980. Last updated year: 2026. Please use registration number 3017987980 when referencing this establishment in official correspondence.