FDA.reportPublic FDA data

CEREGLIDE

Primary DI
10886704086451
Brand
CEREGLIDE
Company
Cerenovus, Inc.
Model
NIC42144U
Catalog number
NIC42144U
Device description
CEREGLIDE 42
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
10886704086451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408645110886704086451

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
10886704080428ENPOWERDCB2000500DCB20005002016-09-12
10886704082293CEREBASEGS9090SDGS9090SD2020-04-13
10886704082316CEREBASEGS9080SDGS9080SD2020-04-13
10886704082323CEREBASEGS9095SDGS9095SD2020-04-13
10886704076957DELTAFILLDLF100154DLF1001542016-11-16
10886704076971DELTAFILLDLF100250DLF1002502016-11-16
10886704076988DELTAFILLDLF100258DLF1002582016-11-16
10886704077022DELTAFILLDLF100208DLF1002082016-11-16
10886704077039DELTAFILLDLF100310DLF1003102016-11-16
10886704077046DELTAFILLDLF100308DLF1003082016-11-16
10886704077053DELTAFILLDLF100410DLF1004102015-09-20
10886704077060DELTAFILLDLF100408DLF1004082015-09-20
10886704077077DELTAFILLDLF100510DLF1005102016-11-16
10886704077176DELTAFILLDLF182260DLF1822602016-11-16
10886704077183DELTAFILLDLF182460DLF1824602016-11-16
10886704077244DELTAXSFTDLX100151DLX1001512015-09-20
10886704077251DELTAXSFTDLX100152DLX1001522015-09-20
10886704077268DELTAXSFTDLX100153DLX1001532015-09-20
10886704077275DELTAXSFTDLX100254DLX1002542015-09-20
10886704077282DELTAXSFTDLX100256DLX1002562015-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850074235132Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-07-31
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALQJP2026-07-08
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.NRY2025-10-13
10886704088097CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088103CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088103CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088110CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088110CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704086437CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086475CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086499CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086512CEREGLIDECerenovus, Inc.NRY2025-09-26
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
07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
008537990077258F Base Camp system 2.0 90cmROUTE 92 MEDICALQJP2024-10-14
00810068561944Carrier™ Delivery CatheterBALT USA LLCQJP2023-11-07
00810068561982Carrier™ Delivery CatheterBALT USA LLCQJP2023-11-07