Cerenovus, Inc.

FDA Device Registration & Listing · Ciudad Juarez, Chihuahua Mexico, MX · Registration 3008264254

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
3008264254
FEI Number
3008264254
Entity Name
Cerenovus, Inc.
City/State/Country
Ciudad Juarez, Chihuahua Mexico, MX
Establishment Address
Calle Circuito Interior Norte #1820, Parque Industrial Salvarcar, Ciudad Juarez, Chihuahua Mexico C.P. 32574, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Cerenovus, Inc. (Owner Number: 9026915)
Owner / Operator Contact Address
6303 Waterford District Dr Ste 315, --, Miami, FL 33126, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220040
PMA Number
N/A

All Registered Proprietary Names

CEREBASE DA Guide Sheath Prowler Select Plus Straight 160cm EMBOGUARD Balloon Guide Catheter RAPID TRANSIT Infusion Catheter EmboTrap ll Revascularization Device POWLER Infusion Catheter TRANSIT Infusion Catheter RAPID TRANSIT Infusion Catheter TRUFILL DCS Orbit ENVOY 7Fr Guiding Catheter ENVOY Guiding Catheter TRANSIT Infusion Catheter TRUFILL DCS Prowler EX Microcatheter Prowler Select Plus Microcatheter EMBOGUARD Balloon Guide Catheter TRANSIT Infusion Catheter Transit Infusion Catheter TRANSIT Infusion Catheter CEREGLIDE 71 Catheter System Orbit GALAXY Detachable Coil System CEREGLIDE 71 Intermediate Catheter Trufill DCS Orbit Detatchable Coil System CEREGLIDE 57 Intermediate Catheter CEREGLIDE 42 Intermediate Catheter CEREGLIDE 92 Intermediate Catheter EMBOTRAP III Revascularization Device Prowler Select EmboTrap ll Revascularization Device ENVOY (DA) Distal Access Guiding Catheter ENVOY Distal Access (DA) Guiding Catheter ENVOY DA Guiding Catheter CEREGLIDE 92 Catheter System CEREPAK Detachable Coil Systems

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2020-03-02
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-06-30
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-09-30
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-10-23
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-09-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2015-12-21
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2008-10-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-04-23
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-10-23
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2008-10-23
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2008-10-23
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2021-09-03
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-09-03
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-09-03
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-09-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-10-23
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-10-23
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-10-23
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-09-02
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-09-02
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2010-06-11
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2010-06-11
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-03-29
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2012-12-26
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-11-12
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-01-23
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-09-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-10-23
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-09-30
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-04-29
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-05-14
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2022-07-18
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2022-07-18

Official Correspondent

Samuel Shimp

US Agent Details

Samuel Shimp Email: sshimp@its.jnj.com Phone: (757) 7909275

Related Public Records

Same Entity

Cerenovus, 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
1226348 Cerenovus, Inc. RAYNHAM, MA, US
3007628272 Cerenovus, Inc. Miami, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05
K924661 Baxter Healthcare Corp SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER 1993-04-08
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2025 Stryker Neurovascular 2
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008264254. Last updated year: 2026. Please use registration number 3008264254 when referencing this establishment in official correspondence.
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