OPSENS INC.

FDA Device Registration & Listing · Quebec City, CA · Registration 3008061490

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008061490
FEI Number
3008061490
Entity Name
OPSENS INC.
City/State/Country
Quebec City, CA
Establishment Address
750, Boulevard du Parc Technologique, Quebec City G1P 4S3, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Opsens Inc. (Owner Number: 10049773)
Owner / Operator Contact Address
750, Boulevard du Parc Technologique, Quebec City, CA-QC G1P 4S3, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202943
PMA Number
N/A

All Registered Proprietary Names

OptoWire OptoWire Deux SavvyWire OptoMonitor 3 OptoWire III OptoMonitor 3 OptoMonitor 2 PacePro Wire OptoMonitor 3 OptoMonitor 3

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2016-02-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-02-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2022-09-15
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2022-09-15
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2022-09-15
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2026-01-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-01-13
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2020-01-13
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2025-05-29
PPW Adjunctive Cardiovascular Status Indicator Cardiovascular Class 2 870.2200 2025-05-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-09-14
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2016-09-14
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2024-05-28
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-05-28
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2020-06-19
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2021-04-15

Official Correspondent

Marc Chaunet

US Agent Details

Julie Ryan Business: Haemonetics Corporation Email: julie.ryan@haemonetics.com Phone: (781) 6900575

Related Public Records

Same Entity

Opsens Inc.
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
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008061490. Last updated year: 2026. Please use registration number 3008061490 when referencing this establishment in official correspondence.
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