Cerenovus, Inc.

FDA Device Registration & Listing · Miami, FL, US · Registration 3007628272

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
3007628272
FEI Number
3007628272
Entity Name
Cerenovus, Inc.
City/State/Country
Miami, FL, US
Establishment Address
6303 Waterford District Drive, Suites 215 and 315, Miami, FL 33126, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
K214025
PMA Number
N/A

All Registered Proprietary Names

CERENOVUS Large Bore Catheter BRAVO Flow Diverter TRANSIT Infusion Catheter Transit Infusion Catheter Orbit GALAXY Detachable Coil System Ascent Occlusion Ballon Catheter Cerenovus Aspiration Tubing Set Trufill DCS Orbit Detatchable Coil System Prowler EX Microcatheter Prowler Select Plus Microcatheter POWLER Infusion Catheter TRANSIT Infusion Catheter RAPID TRANSIT Infusion Catheter Essence Guidewires PROWLER Infusion Catheters Agility (0.10) YOGA Microcatheter CEREBASE DA Guide Sheath CERENOVUS Large Bore Catheter CERENOVUS Aspiration Tubing Set GALAXY G3 XSFT Microcoil Delivery System DELTAXSFT Microcoil Delivery System MICRUSFRAME Microcoil Delivery System GALAXY G3 Microcoil Delivery System DELTAFILL Microcoil Delivery System ENVOY (DA) Distal Access Guiding Catheter ENVOY Distal Access (DA) Guiding Catheter ENVOY DA Guiding Catheter Agility (0.16) Steerable Guidewires CEREPAK Detachable Coil Systems CEREGLIDE 92 Intermediate Catheter ENVOY Distal Access Guiding Catheter TRANSIT Infusion Catheter GALAXY G3 Mini Microcoil Delivery System Neuroscout Steerable Guidewire Agility Steerable Guidewire TRANSIT Infusion Catheter CEREGLIDE 71 Catheter System RAPID TRANSIT Infusion Catheter NeuroScout Steerable Guidewire ENVOY Guiding Catheter CEREGLIDE 92 Catheter System TRUFILL n-Butyle Cyanoacrylate Enterprise VRD & DS CEREGLIDE 57 Intermediate Catheter CEREGLIDE 42 Intermediate Catheter TRUFILL DCS Prowler Plus Infusion Catheter Prowler Select CEREGLIDE 71 Intermediate Catheter Vascular Occlusion System Prowler XS Microcatheter Prowler Select LP ES Microcatheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-11-11
OUT Intracranial Aneurysm Flow Diverter Unknown Class 3 N/A 2018-08-09
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-10-23
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-10-23
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
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2011-06-14
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2024-08-13
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2012-12-26
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
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2015-12-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-10-23
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-10-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-10-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-08-14
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2020-03-02
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2020-07-27
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2017-11-06
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2017-11-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-04-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-10-23
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
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-01-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-05-24
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-10-23
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2017-10-19
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2017-10-19
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-12-06
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
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-10-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2010-06-07
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-06-11
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2015-06-23
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2015-06-23
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-05-14
SGU Neurovascular Liquid Embolic Agent Unknown Class 3 N/A 2008-10-23
KGG Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations Unknown Class 3 N/A 2008-10-23
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2008-10-23
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-11-12
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
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-10-23
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-10-23
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2023-03-29
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2012-12-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-05-12
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2022-05-12
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2022-05-12

Official Correspondent

Samuel Shimp

US Agent Details

No US Agent registered (Local establishment).

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
3008264254 Cerenovus, Inc. Ciudad Juarez, Chihuahua Mexico, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19
K082339 Endocross, Ltd. ENABLER-P SUPPORT CATHETER 2008-11-20
K210009 CenterPoint Systems, LLC Guiding Catheter 2021-11-24

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 3007628272. Last updated year: 2026. Please use registration number 3007628272 when referencing this establishment in official correspondence.
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