FDA.reportPublic FDA data

VISTA BRITE TIP

Primary DI
20705032100745
Brand
VISTA BRITE TIP
Company
Cordis US Corp.
Model
670-190-00M
Catalog number
670-190-00M
Device description
VBT GC 6F .070 IM
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021593000MODIFICATION TO ENVOY AND VISTA BRITE TIPCordis Corp.2002-06-13DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032100745PackageGS15In Commercial Distribution
10705032100748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503210074520705032100745
1070503210074810705032100748

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118274128
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032000086RAIN Sheath® Tibial Pedal IntroducerTP506410NTP506410N2023-05-05
10705032000093RAIN Sheath® Tibial Pedal IntroducerTP506410STP506410S2023-05-05
10705032078894RAIN Sheath Transradial506616H506616H2018-10-09
10705032078924RAIN Sheath Transradial506716H506716H2018-10-09
10705032078931RAIN Sheath Transradial506416S506416S2018-10-09
10705032078948RAIN Sheath Transradial506610S506610S2018-10-09
10705032078955RAIN Sheath Transradial506710S506710S2018-10-09
10705032078962RAIN Sheath Transradial506410H506410H2018-10-09
10705032078979RAIN Sheath Transradial506510H506510H2018-10-09
10705032078986RAIN Sheath Transradial506716S506716S2018-10-09
10705032078993RAIN Sheath Transradial506416H506416H2018-10-09
10705032079006RAIN Sheath Transradial506616S506616S2018-10-09
10705032079013RAIN Sheath Transradial506710H506710H2018-10-09
10705032079037RAIN Sheath Transradial506610H506610H2018-10-09
10705032082068RAIN Sheath Transradial506410P20G506410P20G2020-12-17
10705032082075RAIN Sheath Transradial506716P22G506716P22G2020-12-17
10705032082082RAIN Sheath Transradial506616P22G506616P22G2020-12-17
10705032082105RAIN Sheath Transradial506510P22G506510P22G2020-12-17
10705032082112RAIN Sheath Transradial506510P20G506510P20G2020-12-17
10705032082129RAIN Sheath Transradial506516N506516N2020-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001552777687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.DQY2026-10-29
07613327682427Excelsior ReachStryker CorporationDQY2026-10-29
07613327682434Excelsior ReachStryker CorporationDQY2026-10-29
07613327682441Excelsior ReachStryker CorporationDQY2026-10-29
07613327682458Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationDQY2026-10-29
07613327682496Excelsior ReachStryker CorporationDQY2026-10-29
07613327682526Excelsior ReachStryker CorporationDQY2026-10-29
07613327682571Excelsior ReachStryker CorporationDQY2026-10-29
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
00884450838167Ventrax™Merit Medical Systems, Inc.DQY2026-01-13
00884450838174Ventrax™Merit Medical Systems, Inc.DQY2026-01-13
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14