FDA.reportPublic FDA data

VascuTrak®

Primary DI
00801741062148
Brand
VascuTrak®
Company
Bard Peripheral Vascular, Inc.
Model
V1850200S
Catalog number
V1850200S
Device description
VascuTrak® PTA Dilatation Catheter 5 mm x 200 mm, 80 cm catheter
Published
2016-08-19
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
PNOCatheter, percutaneous, cutting/scoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNOCatheter, Percutaneous, Cutting/ScoringCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103459000VASCUTRAK PTA DILATATION CATHETERC.R. Bard, Inc.2010-12-13PNO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741062148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741062148008017410621488017410621480801741062148

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741067877Seeker®SK13514SK135142016-05-31
00801741067884Seeker®SK13518SK135182016-05-31
00801741067891Seeker®SK13535MSK13535M2016-05-31
00801741067907Seeker®SK15014SK150142016-05-31
00801741067914Seeker®SK15018SK150182016-05-31
00801741067921Seeker®SK15035MSK15035M2016-05-31
00801741067938Seeker®SK6535MSK6535M2016-05-31
00801741067945Seeker®SK9018SK90182016-05-31
00801741067952Seeker®SK9035MSK9035M2016-05-31
00801741201271ReconSCCTO110ASCCTO110A2021-10-04
00801741201288ReconSCCTO110SCCTO1102021-10-04
00801741201295ReconSCCTO110ATSCCTO110AT2021-10-04
00801741201301ReconSCCTO110TSCCTO110T2021-10-04
00801741182754WavelinQW04200W042002019-02-22
00801741067792SIDEKICK®SD110SD1102016-09-13
00801741067808SIDEKICK®SD110ASD110A2016-09-13
00801741067815SIDEKICK®SD110ATSD110AT2016-09-13
00801741067822SIDEKICK®SD110TSD110T2016-09-13
00801741067839SIDEKICK®SD70SD702016-09-13
00801741067846SIDEKICK®SD70ASD70A2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923533801330Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801347Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801354Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801361Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801378Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801385Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801392Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801408Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801415Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801422Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801439Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801446Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801453Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801460Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801477Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801484Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801491Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801507Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801514Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801521Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801538Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801545Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801552Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801569Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801576Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801583Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801590Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801606Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801613Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30
06923533801620Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-07-30