Cerenovus, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12263483002947440Cerenovus, Inc.1N2026-01-01325 Paramount Drive RAYNHAM MA US 02767
30076282723007628272Cerenovus, Inc.1N2026-01-016303 Waterford District Drive Suites 215 and 315 Miami FL US 33126

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10886704086437CEREGLIDE - CEREGLIDE 42+1(800)255-2500xx@xx.xx
10886704086451CEREGLIDE - CEREGLIDE 42+1(800)255-2500xx@xx.xx
10886704086475CEREGLIDE - CEREGLIDE 42+1(800)255-2500xx@xx.xx
10886704088097CEREGLIDE - CEREGLIDE 71 INNERGLIDE 7 125 cm 165 cm 0.071 in (1.80 mm) 0.030 in (0.76 mm) 0.082 in (2.08 mm) 0.042 in (1.07 mm) 0.0825 in (2.10 mm) 0.059 in (1.50 mm) 0.085 in (2.16 mm) Minimum Guide Diameter+1(800)255-2500xx@xx.xx
10886704088103CEREGLIDE - CEREGLIDE 71 INNERGLIDE 7 115 cm 165 cm 0.071 in (1.80 mm) 0.030 in (0.76 mm) 0.082 in (2.08 mm) 0.042 in (1.07 mm) 0.0825 in (2.10 mm) 0.059 in (1.50 mm) 0.085 in (2.16 mm) Minimum Guide Diameter+1(800)255-2500xx@xx.xx
10886704088110CEREGLIDE - CEREGLIDE 71 INNERGLIDE 7 137 cm 165 cm 0.071 in (1.80 mm) 0.030 in (0.76 mm) 0.082 in (2.08 mm) 0.042 in (1.07 mm) 0.0825 in (2.10 mm) 0.059 in (1.50 mm) 0.085 in (2.16 mm) Minimum Guide Diameter+1(800)255-2500xx@xx.xx
10886704088141CEREGLIDE - CEREGLIDE 71 INNERGLIDE 7 132 cm 165 cm 0.071 in (1.80 mm) 0.030 in (0.76 mm) 0.082 in (2.08 mm) 0.042 in (1.07 mm) 0.0825 in (2.10 mm) 0.059 in (1.50 mm) 0.085 in (2.16 mm) Minimum Guide Diameter+1(800)255-2500xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
525231037253535P990040TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEMKGG2000-09-25
1687571037253535P990040TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEMKGG2000-09-25
525231740959003P890055MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMLKK1996-03-11
525231415044459P800036INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4LKK1982-03-03
525231649535187K993266PROWLER PLUS INFUSION CATHETERKRA1999-10-28
1687571649535187K993266PROWLER PLUS INFUSION CATHETERKRA1999-10-28
525232062825161K992591CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITSGWM1999-10-15
525231256997126K992173SIPHONGUARD CSF CONTROL DEVICEJXG2000-04-07
525231302411416K991646AGILITY STEERABLE GUIDEWIREDQX1999-09-23
1687571302411416K991646AGILITY STEERABLE GUIDEWIREDQX1999-09-23
525231510339314K991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITGWM1999-07-09
525231879755566K983483VASCULAR OCCLUSION SYSTEMHCG1999-03-24
1687571879755566K983483VASCULAR OCCLUSION SYSTEMHCG1999-03-24
525231994572417K982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERHCI1998-12-18
525231933996689K974739HAKIM PROGRAMMABLE VALVE SYSTEMJXG1998-07-01
525231757714936K974088CODMAN INTRACRANIAL BOLTGWM1998-01-09
525232070996682K973774CODMAN HAKIM MICRO PRECISION VALVEJXG1997-12-29
525231576763139K972518TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETERKRA1997-11-04
1687571576763139K972518TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETERKRA1997-11-04
525232007087101K963499MIRROR FINISH BIPOLAR FORCEPSGEI1996-10-08
525231295294370K955637ESSENCE GUIDEWIREDQX1996-03-11
1687571295294370K955637ESSENCE GUIDEWIREDQX1996-03-11
525231492140201K954949TRANSIT INFUSION CATHETER WITH SIDEHOLESKRA1995-12-22
1687571492140201K954949TRANSIT INFUSION CATHETER WITH SIDEHOLESKRA1995-12-22
525231336903770K952874TRANSIT INFUSION CATHETERKRA1995-08-21
1687571336903770K952874TRANSIT INFUSION CATHETERKRA1995-08-21
525231777101689K950910TRANSIT-2 INFUSION CATHETERDQO1995-08-08
1687571777101689K950910TRANSIT-2 INFUSION CATHETERDQO1995-08-08
525231284696181K945585COMAN(R) CU-11 MODEL NUMBER 82-6634GWM1995-10-26
525231344695654K944222CODMAN-MEDOS VALVE SHUNT SYSTEMJXG1995-07-28
525231937077081K936282TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)DQO1994-07-18
1687571937077081K936282TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)DQO1994-07-18
525231363716850K936260TRANSIT INFUSION CATHETERDQO1994-05-31
1687571363716850K936260TRANSIT INFUSION CATHETERDQO1994-05-31
525231972015433K934196CODMAN QUICK SHUNT KIT, CAT. #82-6570GWG1994-04-12
525231878928662K931281MICRO ENDOSCOPIC ELECTRODE (ME2)GCJ1993-07-23
525231707942125K914479MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCERGWM1994-03-07
525231595949624K905433CODMAN DISPOSABLE SCALP CLIP APPLIERHBO1991-02-21
525231329122202K902544SUNDT AVM MICRO CLIPHCI1990-09-20
525231273332380K896541MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-IIIGEI1990-01-29
525231304996200K890648MALIS BIPOLAR CORD/IRRIGATION TUBING SETGEI1989-03-03
525232065464889K883607PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERGYK1988-09-30
525231776591064K880402CODMAN SURGICAL PATTIEHBA1988-03-02
525231344530678K875018GHAJAR GUIDE TWIST DRILLHBG1988-01-28
525231085594369K861822MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAIGWO1986-07-11
525231584943928K854413MALIS IRRIGATION SYSTEMGEI1985-12-02
525231963307586K853770CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KITGWM1986-10-06
525231980793163K851487CODMAN DISPOSABLE BIPOLAR CARDGEI1985-05-03
525231080727522K840003DISPOSABLE ICP KIT DIFF. SIZESGWM1984-02-28
525231516548602K834477DISPOS. SCOTT CANNULAS 16-1054 ETC.HCA1984-03-19
525231613498728K791101DISPOSABLE PERFORATORS, JACOBS, HUDSONHBF1979-08-28
1687571535716851K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFHCG2026-08-14
1687572016663247K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY2026-08-13
1687571202438329K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetNRY2025-08-22
1687572026830689K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterQJP2024-10-16
1687571101011954K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing SetNRY2024-10-16
1687571979597356K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetNRY2024-01-17
1687571014572605K233982CEREGLIDE 92 Catheter SystemQJP2024-05-09
1687571446823653K230726CEREGLIDE 92 Intermediate CatheterQJP2023-11-29
1687571034563592K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetNRY2023-03-09
1687571359868403K221930CEREGLIDE 71 Intermediate CatheterQJP2023-03-09
1687571701167504K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil SystemsHCG2022-07-14
1687572065370633K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterKRA2022-04-12
1687571640772085K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery SystemsHCG2021-05-28
1687571565673846K210838PROWLER SELECT PLUS; PROWLER EXKRA2021-08-25
1687571525538687K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY2020-07-20
1687571958154175K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cmQJP2020-02-27
1687571077308637K191237CERENOVUS Large Bore CatheterDQY2019-11-08
525231932124118K183581Codman Disposable PerforatorsHBF2019-01-20
525231402817138K183526Codman Electrosurgical Generator, Foot PedalGEI2019-04-11
525231792509389K183406CereLink ICP Monitor, CereLink ICP Extension CableGWM2019-01-11
525231887225659K182801Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting CableGEI2018-11-27
525231423793192K181902Codman Certas Plus Electronic Tool KitJXG2018-10-25
525231470700937K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitGWM2017-11-08
525231996488647K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagJXG2017-10-16
525231782210697K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG2017-10-03
1687571594974826K171862GALAXY G3 Mini Microcoil Delivery SystemHCG2017-09-25
1687571937747566K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery SystemHCG2017-07-14
1687571969116148K171653YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY2017-07-03
1687571284190584K162563YOGA MicrocatheterDQY2017-01-05
525232063123933K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitGWM2016-08-19
1687571521967021K150319MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMSHCG2015-06-12
1687571033952703K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector CableHCG2014-12-24
525231839638740K140307ENVOY GUIDING CATHETERDQY2014-04-21
1687571839638740K140307ENVOY GUIDING CATHETERDQY2014-04-21
1687572008248540K140080ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XBDQY2014-04-24
525231107528788K133625AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &MOF2014-02-24
1687571107528788K133625AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &MOF2014-02-24
525231774794046K123560VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEMHCG2013-01-25
1687571774794046K123560VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEMHCG2013-01-25
525231429715573K122118HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEMJXG2012-08-03
525231036044735K121776AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIREDQX2012-08-14
1687571036044735K121776AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIREDQX2012-08-14
1687571775393931K120229ENVOY DISTAL ACCESS GUIDING CATHETERDQY2012-02-24
1687571404604886K112828REVIVE INTERMEDIATE CATHETER (REVIVE IC)DQY2011-10-25
525231366600220K110751CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETERJXG2011-05-09
1687571958011279K103780MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIOMJN2011-01-26
525231931922903K102961HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODMJXG2011-02-18
525231356935555K102589CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETERJXG2011-01-14
525232017096015K100351NEUROSCOUT STEERABLE GUIDEWIREDQX2010-03-16
1687572017096015K100351NEUROSCOUT STEERABLE GUIDEWIREDQX2010-03-16
525231905916277K093973TRUFILL DCS ORBIT DETACHABLE COIL SYSTEMHCG2010-05-26
1687571905916277K093973TRUFILL DCS ORBIT DETACHABLE COIL SYSTEMHCG2010-05-26
525231055260598K093184ENVOY GUIDING CATHETERSDQY2009-11-06
1687571055260598K093184ENVOY GUIDING CATHETERSDQY2009-11-06
1687571615523571K092702MICRUS MICROCATHETER, MODEL COURIER 270DQO2009-11-20
525231265946488K091921CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIPHCH2009-09-08
1687571733940074K091504MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00MJN2009-06-19
525231975477175K091346CODMAN HAKIM MICRO II VALVEJXG2009-06-02
525231965573643K090348CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SETJXG2009-03-04
525231054644497K083895CODMAN ISOCOOL BIPOLAR FORCEPSGEI2009-06-23
525231803958211K080967TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBITHCG2008-05-02
1687571803958211K080967TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBITHCG2008-05-02
525232061357338K073336CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231HBF2008-01-04
525231204457860K071962VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)HCG2007-09-26
1687571204457860K071962VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)HCG2007-09-26
525231634786511K071931CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223HBF2007-10-22
525231417080663K071791MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280GXP2007-07-30
1687571585007619K071246MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STRHCG2007-06-01
525231557947716K063254THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEMHCG2006-12-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HCG212026-08-14
JXG202018-10-25
KRA142022-04-12
DQX122012-08-14
GEI112019-04-11
DQY102019-11-08
GWM102019-01-11
DQO72009-11-20
NRY62026-08-13
QJP52024-10-16
HBF42019-01-20
HCA32003-05-14
MOF22014-02-24
MJN22011-01-26
KGG22000-09-25
HCI21998-12-18
HCH12009-09-08
GXP12007-07-30
GXQ12004-06-22
MEA12000-08-23
LKK11996-03-11
GWG11994-04-12
GCJ11993-07-23
HBO11991-02-21
GYK11988-09-30
HBA11988-03-02
HBG11988-01-28
GWO11986-07-11
LKK 11982-03-03

PMN#

GUDID#

200 records. Showing 1-40. Next