FDA.reportPublic FDA data

VIA Microcatheter

Primary DI
00851566003918
Brand
VIA Microcatheter
Company
SEQUENT MEDICAL, INC.
Model
VIA-21-154-01
Catalog number
FGA21154-01
Device description
VIA 21 Microcatheter
Published
2016-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851566003918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851566003918008515660039188515660039180851566003918

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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter0

Contacts#

Phone, Email table
PhoneEmail
949.830.9600customerserviceus@sequentmedical.com

Regulatory Flags#

DUNS number
796807340
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851566003420VIA MicrocatheterVIA-27-154-01FG27154-012016-07-12
00851566003703VIA MicrocatheterVIA-33-133-01FG33133-012016-07-12
00851566003925VIA MicrocatheterVIA-17-154-01FGA17154-012017-03-31
00856956005282WEB Detachment ControllerWDC-1FGA001752019-04-01
00854111006006WEB Aneurysm Embolization SystemW4-4-SFGA25040-0012019-04-01
00854111006013WEB Aneurysm Embolization SystemW4-5-SFGA25050-0012019-04-01
00854111006020WEB Aneurysm Embolization SystemW4-6-SFGA25060-0012019-04-01
00854111006037WEB Aneurysm Embolization SystemW4-7-SFGA25070-0012019-04-01
00854111006044WEB Aneurysm Embolization SystemW4-4-3FGA25040-0302019-04-01
00854111006051WEB Aneurysm Embolization SystemW4-4-4FGA25040-0402019-04-01
00854111006068WEB Aneurysm Embolization SystemW4-5-3FGA25050-0302019-04-01
00854111006075WEB Aneurysm Embolization SystemW4-5-4FGA25050-0402019-04-01
00854111006082WEB Aneurysm Embolization SystemW4-5-5FGA25050-0502019-04-01
00854111006099WEB Aneurysm Embolization SystemW4-6-3FGA25060-0302019-04-01
00854111006105WEB Aneurysm Embolization SystemW4-6-4FGA25060-0402019-04-01
00854111006112WEB Aneurysm Embolization SystemW4-6-5FGA25060-0502019-04-01
00854111006129WEB Aneurysm Embolization SystemW4-6-6FGA25060-0602019-04-01
00854111006136WEB Aneurysm Embolization SystemW4-7-3FGA25070-0302019-04-01
00854111006143WEB Aneurysm Embolization SystemW4-7-4FGA25070-0402019-04-01
00854111006150WEB Aneurysm Embolization SystemW4-7-5FGA25070-0502019-04-01

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Primary DI, Brand, Company table
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00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
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00885403530558FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyKRA2026-08-14
00885403523581VAMPBecton, Dickinson And CompanyKRA2026-07-31
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00885403523734VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyKRA2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyKRA2026-07-31
00885403522331Swan-GanzBecton, Dickinson And CompanyKRA2026-07-24
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B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
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00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
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