FDA.reportPublic FDA data

CEREGLIDE

Primary DI
10886704086109
Brand
CEREGLIDE
Company
Cerenovus, Inc.
Model
SBC92135UG
Catalog number
SBC92135UG
Device description
CEREGLIDE 92 Catheter System CEREGLIDE 92 INNERGLIDE 9135 cm 165 cm 0.092 in (2.34 mm) 0.030 in (0.76 mm) 0.102 in (2.59 mm) 0.042 in (1.07 mm) 0.108 in (2.74 mm) 0.078 in (1.98 mm) 0.113 in (2.87 mm) Minimum Guide Diameter
Published
2024-06-20
Public version status
Update
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
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230726000CEREGLIDE 92 Intermediate CatheterCerenovus, Inc.2023-11-29QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704086109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408610910886704086109

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
DM exempt
true
Lot or batch
true
Expiration date on label
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
10886704088097CEREGLIDECS71125UCS71125U2025-10-13
10886704088103CEREGLIDECS71115UCS71115U2025-10-13
10886704088110CEREGLIDECS71137UCS71137U2025-10-13
10886704088141CEREGLIDECS71132UCS71132U2025-10-13
10886704086437CEREGLIDENIC42132UNIC42132U2025-09-26
10886704086451CEREGLIDENIC42144UNIC42144U2025-09-26
10886704086475CEREGLIDENIC42160UNIC42160U2025-09-26
10886704086499CEREGLIDENIC57115UNIC57115U2025-09-26
10886704086512CEREGLIDENIC57125UNIC57125U2025-09-26
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
04544050121057CELLO II Balloon Guide Catheter, 8F 90cmFUJI SYSTEMS CORPORATIONQJP2026-05-25
0086001552770787 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
0086001552771487 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
06970908212079Paragon 8F Balloon Guide CatheteShanghai Wallaby Medical Technologies Co., Inc.QJP2026-04-15
06970908212086Paragon 8F Balloon Guide CatheteShanghai Wallaby Medical Technologies Co., Inc.QJP2026-04-15
00850014025397APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025403APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025410APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025427APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
05391539370197Millipede 088 Access CatheterPERFUZE LIMITEDQJP2026-03-24
00810201980007SurfRider 13 MicrocatheterKANEKA AMERICAS HOLDING INCQJP2026-02-17
00810201980014SurfRider 13 MicrocatheterKANEKA AMERICAS HOLDING INCQJP2026-02-17
00850074235101Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-16
0086001030636987 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
0086001030637687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
00860013060619Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-02
00840303713128Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
00840303713135Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
00840303713470Carrier XL Delivery CatheterBALT USA LLCQJP2025-10-24
10886704088097CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088103CEREGLIDECerenovus, Inc.QJP2025-10-13
10886704088110CEREGLIDECerenovus, Inc.QJP2025-10-13
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
10886704086512CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086536CEREGLIDECerenovus, Inc.QJP2025-09-26
10886704086550CEREGLIDECerenovus, Inc.QJP2025-09-26