Elana Surgical Kit HUD

Primary DI
M602801H00013
Brand
Elana Surgical Kit HUD
Company
Elana B.V.
Model
1
Catalog number
801-H.00.01
Device description
Elana Surical Kit HUDThe Elana Sutrgical Kit HUD contains: The Elana Laser Catheter 2.0, The Elana Rings 2.6&2.8 and a vacuum extension tube.The Elana Surgical Kit HUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PAXSurgical Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAXSurgical KitUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H080005008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H080005008

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M602801H00013PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular-grafting anastomosis systemAn assembly of sterile devices designed to create an opening between a blood vessel and a vascular graft (native or synthetic) during a vascular surgical procedure [e.g., coronary artery bypass grafting (CABG), or arteriovenous fistula (AVF) grafting]. It typically includes a delivery tool loaded with metallic clips/connectors/couplers (e.g., surgical stainless steel). A blood vessel graft is loaded into the delivery tool, and upon manual actuation of the tool, the fastening devices are deployed through the graft and into the target vessel, and the tool creates an opening in the target vessel (e.g., aortotomy, arteriotomy). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+31302537276info@elana.com

Regulatory Flags#

DUNS number
410404565
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true