FDA.reportPublic FDA data

VIA Microcatheter

Primary DI
00851566003703
Brand
VIA Microcatheter
Company
SEQUENT MEDICAL, INC.
Model
VIA-33-133-01
Catalog number
FG33133-01
Device description
VIA 33 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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132652000VIA MICROCATHETER, VIA PLUS MICROCATHETERSequent Medical, Inc.2013-12-20DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851566003703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851566003703008515660037038515660037030851566003703

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, 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), 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 of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter0.033Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949.830.9600customerserviceus@sequentmedical.com

Regulatory Flags#

DUNS number
796807340
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
00856956005282WEB Detachment ControllerWDC-1FGA001752019-04-01
00851566003420VIA MicrocatheterVIA-27-154-01FG27154-012016-07-12
00851566003918VIA MicrocatheterVIA-21-154-01FGA21154-012016-07-12
00851566003925VIA MicrocatheterVIA-17-154-01FGA17154-012017-03-31
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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