Data / Medical devices / United States / Cerenovus, Inc.

Cerenovus, Inc.: FDA-registered device maker in Miami, FL, United States, 49 510(k) clearances and 1 PMA approval

Name: Cerenovus, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cerenovus, Inc. is registered with the FDA (registration 3007628272) in Miami, FL, United States. It lists 13 device types. The FDA files 49 510(k) clearances and 1 PMA approval under its listings, the newest dated August 14, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Cerenovus, Inc.

FDA registration number: 3007628272
Address: 6303 Waterford District Drive Suites 215 and 315, Miami, FL, United States, 33126
Owner or operator: Cerenovus, Inc. (9026915)
Roles: Manufacturer for export, Specification developer
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, Ascent Occlusion Ballon Catheter, CEREBASE DA Guide Sheath, CEREGLIDE 42 Intermediate Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Continuous Flush	KRA	2	Specification developer	accessdata.fda.gov
Catheter, Intravascular Occluding, Temporary	MJN	2	Specification developer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Specification developer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Specification developer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Specification developer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Specification developer	accessdata.fda.gov
Device, Neurovascular Embolization	HCG	2	Specification developer	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Specification developer	accessdata.fda.gov
Guide, Wire, Catheter, Neurovasculature	MOF	2	Specification developer	accessdata.fda.gov
Intracranial Neurovascular Stent	NJE	f	Specification developer	accessdata.fda.gov
Neurovascular Liquid Embolic Agent	SGU	3	Manufacturer for export, Specification developer	accessdata.fda.gov
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations	KGG	3	Specification developer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Specification developer	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
August 14, 2026	K262419	MICRUSFRAME (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 (MF	HCG	Substantially Equivalent	Cerenovus, Inc.	accessdata.fda.gov
August 13, 2026	K262398	CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set	NRY	Substantially Equivalent	CERENOVUS, Inc.	accessdata.fda.gov
August 22, 2025	K251828	CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set	NRY	Substantially Equivalent	Cerenovus, Inc.	accessdata.fda.gov
October 16, 2024	K241244	CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter	QJP	Substantially Equivalent	Cerenovus, Inc.	accessdata.fda.gov
October 16, 2024	K241221	CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set	NRY	Substantially Equivalent	Cerenovus, Inc.	accessdata.fda.gov
May 9, 2024	K233982	CEREGLIDE 92 Catheter System	QJP	Substantially Equivalent	Cerenovus, Inc.	accessdata.fda.gov
January 17, 2024	K233988	Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set	NRY	Substantially Equivalent	Cerenovus, Inc.	accessdata.fda.gov
November 29, 2023	K230726	CEREGLIDE 92 Intermediate Catheter	QJP	Substantially Equivalent	Cerenovus, Inc.	accessdata.fda.gov
March 9, 2023	K221934	CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set	NRY	Substantially Equivalent	Cerenovus, Inc.	accessdata.fda.gov
March 9, 2023	K221930	CEREGLIDE 71 Intermediate Catheter	QJP	Substantially Equivalent	Cerenovus, Inc.	accessdata.fda.gov
July 14, 2022	K220040	CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems	HCG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
April 12, 2022	K214025	PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter	KRA	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
August 25, 2021	K210838	PROWLER SELECT PLUS; PROWLER EX	KRA	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
May 28, 2021	K211344	MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems	HCG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
July 20, 2020	K193380	CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set	NRY	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
February 27, 2020	K192804	CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm	QJP	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
November 8, 2019	K191237	CERENOVUS Large Bore Catheter	DQY	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
September 25, 2017	K171862	GALAXY G3 Mini Microcoil Delivery System	HCG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
July 14, 2017	K171747	MICRUSFRAME 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 System	HCG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
January 5, 2017	K162563	YOGA Microcatheter	DQY	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
June 12, 2015	K150319	MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS	HCG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
December 24, 2014	K142429	CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable	HCG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
April 24, 2014	K140080	ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB	DQY	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
April 21, 2014	K140307	ENVOY GUIDING CATHETER	DQY	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
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
February 24, 2012	K120229	ENVOY DISTAL ACCESS GUIDING CATHETER	DQY	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
May 26, 2010	K093973	TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM	HCG	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
March 16, 2010	K100351	NEUROSCOUT STEERABLE GUIDEWIRE	DQX	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
November 6, 2009	K093184	ENVOY GUIDING CATHETERS	DQY	Substantially Equivalent	Codman & Shurtleff, Inc.	accessdata.fda.gov
June 19, 2009	K091504	MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00	MJN	Substantially Equivalent	Micrus Endovascular Corporation	accessdata.fda.gov
May 2, 2008	K080967	TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT	HCG	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
September 26, 2007	K071962	VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)	HCG	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
June 1, 2007	K071246	MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR	HCG	Substantially Equivalent	Micrus Endovascular Corporation	accessdata.fda.gov
May 22, 2002	K021591	PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS	KRA	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
March 7, 2002	K014041	TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM	HCG	Substantially Equivalent	Cordis Neurovascular	accessdata.fda.gov
March 1, 2001	K010511	MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES	DQX	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
January 8, 2001	K003925	PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS	KRA	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
April 14, 2000	K001033	AGILITY STEERABLE GUIDEWIRE	DQX	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
October 28, 1999	K993266	PROWLER PLUS INFUSION CATHETER	KRA	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 24, 1999	K983483	VASCULAR OCCLUSION SYSTEM	HCG	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
November 4, 1997	K972518	TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER	KRA	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
March 11, 1996	K955637	ESSENCE GUIDEWIRE	DQX	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
December 22, 1995	K954949	TRANSIT INFUSION CATHETER WITH SIDEHOLES	KRA	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
August 21, 1995	K952874	TRANSIT INFUSION CATHETER	KRA	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
August 8, 1995	K950910	TRANSIT-2 INFUSION CATHETER	DQO	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
July 18, 1994	K936282	TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)	DQO	Substantially Equivalent	Cordis Neurovascular, Inc.	accessdata.fda.gov
May 31, 1994	K936260	TRANSIT INFUSION CATHETER	DQO	Substantially Equivalent	Cordis Corp.	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
October 2, 2025	97814	Class I	Ongoing	CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X	Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.	accessdata.fda.gov

Compare with other makers

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.