CerebroFlo EVD Catheter Set

Primary DI
00866614000108
Brand
CerebroFlo EVD Catheter Set
Company
ARKIS BIOSCIENCES INC.
Model
37.550.101
Catalog number
37.550.101
Device description
The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through the drainage holes near the catheter's tip. The catheter is barium-sulfate impregnated to provide radiopacity. The CerebroFlo EVD Catheter is provided with a Stylette, Trocar, Barbed Leur Connector, Male Leur Cap, and a suture clip.
Published
2017-12-15
Public version status
Update
Distribution status
Not 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
JXGShunt, Central Nervous System And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170599000SureFlo EVD CatheterArkis Biosciences, Inc.2017-08-31JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866614000108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866614000108008666140001088666140001080866614000108

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral infusion/drainage catheter, short-termA sterile flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Centimeter
Outer Diameter3.3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)247-5383info@arkisbiosciences.com
+1(800)654-2873custserv@integralife.com

Regulatory Flags#

DUNS number
078846878
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10866614000181Subcutaneous Guidewire - Medium41.240.50241.240.5022018-12-14
10866614000198Subcutaneous Guidewire - Large41.240.50341.240.5032018-12-14
10866614000105CerebroFlo EVD Catheter Set37.550.50137.550.5012019-10-24
00866614000115Galea Elevator41.312.10141.312.1012019-04-25
00866614000122Single Pass Tunneling Guidewire - Large41.157.10341.157.1032018-12-14
00866614000139Single Pass Tunneling Guidewire - Medium41.157.10241.157.1022018-12-14
00866614000146Single Pass Tunneling Guidewire - Small41.157.10141.157.1012018-12-14
00866614000153Precision Tunneler - Small41.020.50141.020.5012018-12-13
00866614000160Precision Tunneler - Medium41.020.50241.020.5022018-12-13
00866614000177Precision Tunneler - Large41.020.50341.020.5032018-12-13

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