FDA.reportPublic FDA data

GORE® Tri-Lobe Balloon Catheter

Primary DI
00733132619849
Brand
GORE® Tri-Lobe Balloon Catheter
Company
W. L. Gore & Associates, Inc.
Model
TBCM1634
Catalog number
TBCM1634
Device description
TRI-LOBE BALLOON CATHETER 18Fr
Published
2025-06-11
Public version status
New
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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250410000GORE® Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.2025-06-02DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00733132619849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733132619849007331326198497331326198490733132619849

GMDN Terms#

Term, Definition table
TermDefinition
Aortic endovascular implant post-dilation balloon catheterA flexible tube or shaft with an inflatable balloon(s) at its distal end intended for percutaneous introduction to dilate and stabilize within the aorta a previously deployed aortic endovascular implant (e.g., stent-graft) [not included]; it is not intended for vessel occlusion. It typically includes a guidewire, inflation port, and haemostasis valve. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French
Length104Centimeter
Length108Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)528-8763mpdcustomercare@wlgore.com

Regulatory Flags#

DUNS number
967358115
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntHPT040015AHPT040015A2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntHPT050005AHPT050005A2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntHPT050015AHPT050015A2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntHPT060015AHPT060015A2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntHPT350005AHPT350005A2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntHPT350015AHPT350015A2017-02-13
00733132607068GORE PROPATEN Vascular GraftIRH060545AIRH060545A2017-02-13
00733132607129GORE PROPATEN Vascular GraftIRH463845AIRH463845A2017-02-13
00733132607143GORE PROPATEN Vascular GraftIRH473845AIRH473845A2017-02-13
00733132653690GORE SYNECOR Preperitoneal BiomaterialGKWR4040GKWR40402022-11-08
00733132653706GORE SYNECOR Preperitoneal BiomaterialGKWR3030GKWR30302022-11-08
00733132653713GORE SYNECOR Preperitoneal BiomaterialGKWR4050GKWR40502022-11-08
00733132653720GORE SYNECOR Preperitoneal BiomaterialGKWR3535GKWR35352022-11-08
00733132653737GORE SYNECOR Preperitoneal BiomaterialGKWR3040GKWR30402022-11-08
00733132653744GORE SYNECOR Preperitoneal BiomaterialGKWC09GKWC092021-10-05
00733132605798GORE PROPATEN Vascular GraftH060010AH060010A2017-02-13
00733132605811GORE PROPATEN Vascular GraftH060040AH060040A2017-02-13
00733132605835GORE PROPATEN Vascular GraftH060060AH060060A2017-02-13
00733132605859GORE PROPATEN Vascular GraftH060080AH060080A2017-02-13
00733132605873GORE PROPATEN Vascular GraftH080040AH080040A2017-02-13

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