Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1718850

FEI Number

1718850

Entity Name

LivaNova USA, INC.

City/State/Country

ARVADA, CO, US

Establishment Address

14401 WEST 65TH WAY, ARVADA, CO 80004, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LivaNova (Owner Number: 9003795)

Owner / Operator Contact Address

14401 W 65th Way, Arvada, CO 80004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mister Thoracic Catheter EasyFlow and EasyFlow Duo Boncheck Vein Distention System BSVD Transseptal Cannule set EF 72 SMARxT Tubing and Connectors Perfusion Pack Cardioplegia Pack Perfusion Tubing Tubing Perfusion Packs Temperature Probe Venous Return Cannula Protek Duo 31 Fr RD Protek Duo 31 Fr Protek Duo 29 Fr Vent Catheter ProtekDilate Vascular Access Kit Femoral Arterial Cannule Set 17 Fr Vasco Loop Clamps Oxygen Filter Brackets Holders Fittings Femoral Arterial Cannule Set 15 Fr Vein Irrigation Cannula Protek Duo 31 Fr Protek Duo 31 Fr Mini VascuLoop Cardiac Insulation Pads Suction Wand Suction Sump EC Series Connectors Vascular Dilator Kit BRAT2 System and Accessories Dual Stage Venous Cannula Protek Solo 24 FR Aortic Arch Cannula Dual Stage Venous Return Cannula Tri Stage Venous Return Cannula Venous Return Cannula SCCA Cardioplegia Adapter Perfusion Adapter Pressure Monitoring Line Femoral Arterial Cannule Set 14 Fr

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2014-11-06
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2014-11-06
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-06-11
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2007-12-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2025-05-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2007-12-13
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2007-12-18
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2007-12-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-06-11
PZS	Dual Lumen Ecmo Cannula	Cardiovascular	Class 2	870.4100	2024-07-10
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-11-06
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2026-06-11
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-11-06
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2001-02-01
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2007-12-18
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-05-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-05-24
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2007-12-18
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4420	2014-08-27
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2011-01-24
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-02-18
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2007-12-13
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-06-11
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-02-03
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-11-06
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-11-06
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-11-06
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LivaNova

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
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K810894	American Edwards Laboratories	FOGARTY FLEXIBLE CALIBRATOR	1981-05-15
K233702	LivaNova USA, Inc.	SMARxT Tubing and Connectors	2024-08-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Z-0020-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
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.
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

Similar Registrations

Registration Number	Establishment Name	Location
3032611331	CALEB CO., LTD.	Won-Ju-Si Gangwon, KR
3012964172	ELITE MEDTEK(JIANGSU) CO., LTD	Changzhou City Jiangsu, CN
3009217531	Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, DE
3045076544	BEIJING YUEWEI MEDICAL TECHNOLOGY CO., LTD	Beijing, CN
9617429	MEDICOPLAST INTERNATIONAL GMBH	ILLINGEN Saarland, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1718850. Last updated year: 2026. Please use registration number 1718850 when referencing this establishment in official correspondence.