FDA.reportPublic FDA data

VesTraveler®

Primary DI
06934184002809
Brand
VesTraveler®
Company
Dongguan TT Medical, Inc.
Model
SD40034
Published
2024-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230374000Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)Dongguan TT Medical, Inc.2023-06-29LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934184002809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934184002809069341840028096934184002809

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551476865
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934184004100MultiStage®MSO-0630-082025-02-10
06934184004117MultiStage®MSW-0830-082025-02-10
06934184004124MultiStage®MSO-1030-082025-02-10
06934184004131MultiStage®MSO-1230-082025-02-10
06934184004148MultiStage®MSO-1530-082025-02-10
06934184004155MultiStage®MSO-1830-082025-02-10
06934184004162MultiStage®MSO-0630-172025-02-10
06934184004179MultiStage®MSO-0830-172025-02-10
06934184004186MultiStage®MSO-1030-172025-02-10
06934184004193MultiStage®MSO-1230-172025-02-10
06934184004209MultiStage®MSO-1530-172025-02-10
06934184004216MultiStage®MSO-1830-172025-02-10
06934184004223MultiStage®MSO-0630-232025-02-10
06934184004230MultiStage®MSO-0830-232025-02-10
06934184004254MultiStage®MSO-1230-232025-02-10
06934184004261MultiStage®MSO-1530-232025-02-10
06934184004278MultiStage®MSO-1830-232025-02-10
06934184004285MultiStage®MSO-0655-082025-02-10
06934184004292MultiStage®MSO-0855-082025-02-10
06934184004308MultiStage®MSO-1055-082025-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810219610088FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610095FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610101FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
06971591769062Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769079Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769086Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769093Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769109Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769116Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769123Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769130Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769147Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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