FDA.reportPublic FDA data

CEREGLIDE

Primary DI
10886704086512
Brand
CEREGLIDE
Company
Cerenovus, Inc.
Model
NIC57125U
Catalog number
NIC57125U
Device description
CEREGLIDE 57
Published
2025-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRYCATHETER, THROMBUS RETRIEVER
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241221000
K241244000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241221000CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.2024-10-16NRY
K241244000CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc.2024-10-16QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704086512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408651210886704086512

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704085317TRUFILL632500NA632500NA2023-10-23
10886704085324TRUFILL632400NA632400NA2023-10-23
10886704029144TRUFILL631-400631-4002014-09-20
10886704029151TRUFILL631-500631-5002014-09-20
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
10886704088097CEREGLIDECS71125UCS71125U2025-10-13
10886704088103CEREGLIDECS71115UCS71115U2025-10-13
10886704088110CEREGLIDECS71137UCS71137U2025-10-13
10886704088141CEREGLIDECS71132UCS71132U2025-10-13
10886704086437CEREGLIDENIC42132UNIC42132U2025-09-26
10886704086451CEREGLIDENIC42144UNIC42144U2025-09-26
10886704086475CEREGLIDENIC42160UNIC42160U2025-09-26
10886704086499CEREGLIDENIC57115UNIC57115U2025-09-26
10886704086536CEREGLIDENIC57132UNIC57132U2025-09-26
10886704086550CEREGLIDENIC57137UNIC57137U2025-09-26
10886704086598CEREGLIDENIC42125U2025-09-26
10886704086611CEREGLIDENIC42115U2025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857545008295Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008301Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008318Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008325Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008332Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00763000974077Riptide™Micro Therapeutics, Inc.NRY2026-03-30
10886704088097CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088097CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088103CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088103CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088141CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704086437CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086451CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086475CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086499CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086536CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086550CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086598CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086611CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704088073CEREGLIDECerenovus, Inc.QJP2025-09-26
00818075011209SocratesSCIENTIA VASCULAR LLCNRY2025-05-27
00818075011209SocratesSCIENTIA VASCULAR LLCQJP2025-05-27
07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
00815948029743ACCESS25 Delivery MicrocatheterPENUMBRA, INC.QJP2024-12-16
00815948029750ACCESS25 Delivery MicrocatheterPENUMBRA, INC.QJP2024-12-16
00815948029767ACCESS25 Delivery MicrocatheterPENUMBRA, INC.QJP2024-12-16