Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009018440

FEI Number

3009018440

Entity Name

Nitinol Devices & Components Costa Rica, S. R. L.

City/State/Country

El Coyol Alajuela, CR

Establishment Address

Coyol Free Zone, Building B14, B15, B25, B28, El Coyol Alajuela 20102, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Confluent Medical Technologies, Inc. (Owner Number: 10033958)

Owner / Operator Contact Address

6263 N. Scottsdale Road, Suite 224, Scottsdale, AZ 85250, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LimFlow Vector MAXI LD Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter POWERFLEX PRO Percutaneous Transluminal Angioplasty Catheter POWERFLEX PRO Percutaneous Transluminal Angioplasty Catheter SLALOM Percutaneous Transluminal Angioplasty (PTA) Catheter LimFlow Extension Stent Graft LimFlow Crossing Stent Graft LimFlow V-Ceiver FLASH Ostial System Shockwave M5 Intravascular Lithotripsy (IVL) Catheter Synthes Synflate Vertebral Balloon System POWERFLEX P3 Percutaneous Transluminal Angioplasty (PTA) Catheter Flash Ostial System OTW PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO 35 Delivery System Cordis SABER 35 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter LimFlow ARC SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER Aquatrack Hydrophilic Nitinol Guidewire AVIATOR PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter FLASH MINI Ostial System Shockwave M5+ Peripheral Intravascular Lithotripsy (IVL) Catheter SABER Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MGZ	Valvulotome	Cardiovascular	Class 2	870.4885	2024-02-06
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2018-08-14
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2017-08-22
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-08-22
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2017-08-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2019-06-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-06-27
QWN	Stent Graft, Infrapopliteal, Venous Arterialization	Unknown	Class 3	N/A	2024-10-04
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2024-02-06
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2020-09-01
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-06-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-06-30
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2020-06-30
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2018-06-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-06-14
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2020-09-01
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2019-01-29
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2021-10-11
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2024-05-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2022-01-05
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2024-10-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-10-21
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2019-01-29
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2020-09-01
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2022-04-27
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2018-06-29

Official Correspondent

Rich Brown

US Agent Details

Rich Brown Email: rich.brown@confluentmedical.com Phone: (262) 7580575

Related Public Records

Same Entity

Confluent Medical Technologies, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007635982	Confluent Medical Technologies, Inc	Fremont, CA, US
3013668043	CONFLUENT MEDICAL TECHNOLOGIES, INC.	Warwick, RI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17
K171251	Creagh Medical	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2017-09-08
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K252512	ABBOTT MEDICAL	Armada 14 NC PTA Catheter	2026-02-13
K142654	Covidien, LLC	Fortrex 0.035 OTW PTA Balloon Catheter	2014-10-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009018440. Last updated year: 2026. Please use registration number 3009018440 when referencing this establishment in official correspondence.