Data / Medical devices / United States / Cerenovus, Inc.
Cerenovus, Inc.: FDA-registered device maker in Raynham, MA, United States, 8 510(k) clearances and 1 PMA approval
Cerenovus, Inc. is registered with the FDA (registration 1226348) in Raynham, MA, United States. It lists 6 device types. The FDA files 8 510(k) clearances and 1 PMA approval under its listings, the newest dated February 24, 2014. 17 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1226348
- FEI number
- 3002947440
- Address
- 325 Paramount Drive, Raynham, MA, United States, 02767
- Owner or operator
- Cerenovus, Inc. (9026915)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- October 23, 2008
- Registered through
- 2026
- Brand names listed
- AGILITY Steerable Guidewire, Agility (0.10), Agility (0.16) Steerable Guidewires, Agility (14), Agility Steerable Guidewire, CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System, Enterprise VRD & DS, Essence Guidewires and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Neurovascular Embolization | HCG | 2 | Manufacturer | accessdata.fda.gov |
| Guide, Wire, Catheter, Neurovasculature | MOF | 2 | Manufacturer | accessdata.fda.gov |
| Intracranial Neurovascular Stent | NJE | f | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Neurovascular Liquid Embolic Agent | SGU | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations | KGG | 3 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2014 | K133625 | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & | MOF | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| August 14, 2012 | K121776 | AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE | DQX | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| March 16, 2010 | K100351 | NEUROSCOUT STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| December 7, 2006 | K063254 | THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent | Cordis Neurovascular, Inc. | accessdata.fda.gov |
| March 1, 2001 | K010511 | MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES | DQX | Substantially Equivalent | Cordis Neurovascular, Inc. | accessdata.fda.gov |
| April 14, 2000 | K001033 | AGILITY STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | Cordis Neurovascular, Inc. | accessdata.fda.gov |
| September 23, 1999 | K991646 | AGILITY STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | Cordis Neurovascular, Inc. | accessdata.fda.gov |
| March 11, 1996 | K955637 | ESSENCE GUIDEWIRE | DQX | Substantially Equivalent | Cordis Neurovascular, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 25, 2000 | P990040 | TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM | KGG | 37 | October 23, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 10, 2015 | 67921 | Class II | Terminated | MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Bac | A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. | accessdata.fda.gov |
| March 5, 2015 | 70659 | Class II | Terminated | CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point | Needle is leaking from hub/needle cannula connection | accessdata.fda.gov |
| September 15, 2014 | 69262 | Class II | Terminated | Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means o | tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus) | accessdata.fda.gov |
| July 3, 2014 | 68837 | Class II | Terminated | Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the m | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). | accessdata.fda.gov |
| December 13, 2013 | 67793 | Class II | Terminated | CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessor | Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves. | accessdata.fda.gov |
| October 11, 2013 | 66493 | Class I | Terminated | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code:; The TRUFILL n-BCA Liquid Embolic System is indicate | Incorrect instructions for use (IFU). | accessdata.fda.gov |
| August 13, 2013 | 65821 | Class I | Terminated | MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen | Drug flow rates exceeding programmed flow rates. | accessdata.fda.gov |
| June 7, 2013 | 65420 | Class I | Terminated | MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine. | Miscalibrated Fill Level Sensor may affect dosing level | accessdata.fda.gov |
| May 16, 2013 | 65179 | Class II | Terminated | Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF | Codman Certas Programmable Valves used for hydrocephalus may not operate properly | accessdata.fda.gov |
| January 11, 2013 | 64158 | Class II | Terminated | NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | Sterility of device may be compromised due to lack of packaging integrity | accessdata.fda.gov |
| February 9, 2012 | 61205 | Not yet classified | Terminated | Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, included in the kit. | Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill | accessdata.fda.gov |
| October 25, 2011 | 60362 | Not yet classified | Terminated | Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the c | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | accessdata.fda.gov |
| March 21, 2011 | 58145 | Not yet classified | Terminated | CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812 | Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length. | accessdata.fda.gov |
| November 30, 2010 | 57340 | Not yet classified | Terminated | Codman Disposable Twist Drill Product code: 80-1200 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures | Packaging defect may compromise sterility of device | accessdata.fda.gov |
| July 16, 2010 | 56279 | Not yet classified | Terminated | Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396 | Surgical Pattie x-ray stripe (radio-opaque marker) became detached | accessdata.fda.gov |
| August 4, 2006 | 36045 | Not yet classified | Terminated | Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730 | Sterility of device is compromised due to package seal defects | accessdata.fda.gov |
| March 11, 2004 | 28678 | Not yet classified | Terminated | Codman Holter Salmon Rickham Reservoir with Ventricular Catheter Catalog Number: 82-1617 | Drainage tips absent from catheter tip | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Guide, Catheter
- All makers of Neurovascular Liquid Embolic Agent
- All makers of Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
- All makers of Device, Neurovascular Embolization
- All makers of Intracranial Neurovascular Stent
- All makers of Guide, Wire, Catheter, Neurovasculature
Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.