FDA.reportPublic FDA data

Wedge

Primary DI
00842429119396
Brand
Wedge
Company
Microvention, Inc.
Model
MCWED21160-088
Catalog number
MCWED21160-088
Device description
Wedge XL
Published
2024-10-18
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
K232542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232542000Wedge XL Delivery CatheterMicroVention, Inc.2024-05-16QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842429119396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842429119396008424291193968424291193960842429119396

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888) 775-0182customerservice@microvention.com

Regulatory Flags#

DUNS number
003263105
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810170012112V-Grip Detachment ControllerVG501VG5012016-09-24
00810170012129Azur Detachment Controller45-400145-40012016-09-24
00810170012136Azur Pushable Helical45-28020245-2802022015-12-29
00810170012143Azur Pushable Helical45-28030245-2803022015-12-29
00810170012150Azur Pushable Helical45-28030445-2803042015-12-29
00810170012167Azur Pushable Helical45-28040245-2804022015-12-29
00810170012174Azur Pushable Helical45-28040445-2804042015-12-29
00810170012181Azur Pushable Helical45-28040645-2804062015-12-29
00810170012198Azur Pushable Helical45-28050445-2805042015-12-29
00810170012204Azur Pushable Helical45-28050645-2805062015-12-29
00810170012211Azur Pushable Helical45-28051045-2805102015-12-29
00810170012228Azur Pushable Helical45-28060645-2806062015-12-29
00810170012235Azur Pushable Helical45-28061045-2806102015-12-29
00810170012242Azur Pushable Helical45-28061445-2806142015-12-29
00810170012259Azur Pushable Helical45-28081045-2808102015-12-29
00810170012266Azur Pushable Helical45-28081445-2808142015-12-29
00810170012273Azur Pushable Helical45-28101445-2810142015-12-29
00810170012440Azur Pushable Helical45-25040445-2504042015-12-29
00810170012457Azur Pushable Helical45-25040645-2504062015-12-29
00810170012464Azur Pushable Helical45-25050445-2505042015-12-29

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