Cerenovus, Inc.

FDA Device Registration & Listing · RAYNHAM, MA, US · Registration 1226348

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
1226348
FEI Number
3002947440
Entity Name
Cerenovus, Inc.
City/State/Country
RAYNHAM, MA, US
Establishment Address
325 Paramount Drive, RAYNHAM, MA 02767, US
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
K991646
PMA Number
N/A

All Registered Proprietary Names

NEUROSCOUT Steerable Guidewire AGILITY Steerable Guidewire BRAVO Flow Diverter NeuroScout Steerable Guidewire CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System Neuroscout Steerable Guidewire Agility Steerable Guidewire Essence Guidewires Agility (0.10)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2014-03-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-03-14
OUT Intracranial Aneurysm Flow Diverter Unknown Class 3 N/A 2018-08-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2010-06-07
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2014-04-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-12-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-10-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-10-23

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
3007628272 Cerenovus, Inc. Miami, FL, US
3008264254 Cerenovus, Inc. Ciudad Juarez, Chihuahua Mexico, MX

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 1226348. Last updated year: 2026. Please use registration number 1226348 when referencing this establishment in official correspondence.
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