Tack Endovascular System (6F, 3.5-6.0mm)

Primary DI
00863328000127
Brand
Tack Endovascular System (6F, 3.5-6.0mm)
Company
Intact Vascular, Inc.
Model
156135061
Catalog number
156135061
Device description
135cm Catheter Length
Published
2019-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QCTScaffold, Dissection Repair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCTScaffold, Dissection RepairUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180034000Tack Endovascular System (6F)Philips Image Guided Therapy Corporation2019-04-11QCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863328000127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863328000127008633280001278633280001270863328000127

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter0.035Inch
Catheter Length135Centimeter
Catheter Working Length135Centimeter
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-865-0214cs@intactvascular.com

Regulatory Flags#

DUNS number
078732453
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003494036Tack Endovascular System (6F, 4.0-8.0mm)2061350612061350612020-02-22
00850003494043Tack Endovascular System (6F, 4.0-8.0mm)2061200612061200612020-02-22
00850003494050Tack Endovascular System (6F, 4.0-8.0mm)2060800612060800612020-02-22
00863328000189Tack Endovascular System (4F, 1.5-4.9mm)1540900411540900412020-04-13
00863328000196Tack Endovascular System (4F, 1.5-4.5mm)1541500411541500412020-04-13
00863328000110Tack Endovascular System (6F, 3.5-6.0mm)1560800611560800612019-11-01
00863328000103Tack Endovascular System (6F, 3.5-6.0mm)1561200611561200612019-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00863328000189Tack Endovascular System (4F, 1.5-4.9mm)Intact Vascular, Inc.QCT2020-04-13
00863328000196Tack Endovascular System (4F, 1.5-4.5mm)Intact Vascular, Inc.QCT2020-04-13
00850003494036Tack Endovascular System (6F, 4.0-8.0mm)Intact Vascular, Inc.QCT2020-02-22
00850003494043Tack Endovascular System (6F, 4.0-8.0mm)Intact Vascular, Inc.QCT2020-02-22
00850003494050Tack Endovascular System (6F, 4.0-8.0mm)Intact Vascular, Inc.QCT2020-02-22
00863328000110Tack Endovascular System (6F, 3.5-6.0mm)Intact Vascular, Inc.QCT2019-11-01
00863328000103Tack Endovascular System (6F, 3.5-6.0mm)Intact Vascular, Inc.QCT2019-04-30