FDA.reportPublic FDA data

CEREGLIDE

Primary DI
10886704085409
Brand
CEREGLIDE
Company
Cerenovus, Inc.
Model
NIC71132U
Catalog number
NIC71132U
Device description
CEREGLIDE 71 Intermediate Catheter 132 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm)
Published
2023-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K221930000
K221934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221930000CEREGLIDE 71 Intermediate CatheterCerenovus, Inc.2023-03-09QJP
K221934000CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.2023-03-09NRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704085409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408540910886704085409

Contacts#

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

Regulatory Flags#

DUNS number
607846297
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704074892ENVOY778-258-00B77825800B2026-09-19
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
10886704088073CEREGLIDENIC42152UNIC42152U2025-09-26
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
10886704085355CEREGLIDENIC71115UNIC71115U2023-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001552777687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-10-29
07613327682427Excelsior ReachStryker CorporationQJP2026-10-29
07613327682434Excelsior ReachStryker CorporationQJP2026-10-29
07613327682441Excelsior ReachStryker CorporationQJP2026-10-29
07613327682458Excelsior ReachStryker CorporationQJP2026-10-29
07613327682465Excelsior ReachStryker CorporationQJP2026-10-29
07613327682496Excelsior ReachStryker CorporationQJP2026-10-29
07613327682526Excelsior ReachStryker CorporationQJP2026-10-29
07613327682571Excelsior ReachStryker CorporationQJP2026-10-29
07613327694796Broadway 8Stryker CorporationQJP2026-10-27
00850085183002FreeClimb 46 Catheter x125cmROUTE 92 MEDICALQJP2026-10-12
00850085183019FreeClimb 46 Catheter x143cmROUTE 92 MEDICALQJP2026-10-12
00850085183026FreeClimb 46 Catheter x125cm with Tenzing 4ROUTE 92 MEDICALQJP2026-10-12
00850085183033FreeClimb 46 Catheter x143 cm with Tenzing 4ROUTE 92 MEDICALQJP2026-10-12
00850085183040Tenzing 4 Delivery CatheterROUTE 92 MEDICALQJP2026-10-12
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCQJP2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCQJP2026-10-01
05391539370296Millipede88 CatheterPERFUZE LIMITEDNRY2026-08-21
00850074235132Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-07-31
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALQJP2026-07-08
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
00850074235101Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-16
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24