FDA.reportPublic FDA data

SPEX18

Primary DI
00856492005326
Brand
SPEX18
Company
REFLOW MEDICAL, INC.
Model
SPX18090US
Catalog number
SPX18090US
Device description
Spex Shapeable Support Catheter, 18X90cm
Published
2018-08-06
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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173662000speX Support CatheterReflow Medical, Inc.2017-12-20DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856492005326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856492005326008564920053268564920053260856492005326

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
Length90Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949.481.0399quality@reflowmedical.com

Regulatory Flags#

DUNS number
962545294
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856492005692coraForceFRC14150US2020-12-18
00856492005708coraForceFRC14135US2020-12-18
00856492005715coraFlexFLX14135US2020-12-18
00856492005722coraFlexFLX14150US2020-12-18
00856492005142WINGMAN14WGM14150USWGM14150US2016-09-23
00856492005159WINGMAN14WGM14135USWGM14135US2016-09-23
00856492005166WINGMAN35WGM35135USWGM35135US2016-09-23
00856492005173WINGMAN35WGM35090USWGM35090US2016-09-23
00856492005180WINGMAN35WGM35065USWGM35065US2016-09-23
00856492005197WINGMAN14WGM14065USWGM14065US2016-09-23
00856492005234WINGMAN18WGM18090USWGM18090US2016-09-23
00856492005241WINGMAN18WGM18135USWGM18135US2016-09-23
00856492005258WINGMAN18WGM18150USWGM18150US2016-09-23
00856492005296WINGMAN14CWMC14090US2017-09-20
00856492005302WINGMAN14CWMC14135US2017-09-20
00856492005319WINGMAN14CWMC14150US2017-09-20
00850025525169Spur Peripheral Retrievable Stent SystemBSPUR365135US2025-06-06
00850025525176Spur Peripheral Retrievable Stent SystemBSPUR460135US2025-06-06
00850025525213SINCSINC35090US2024-02-19
00850025525220SINCSINC35135US2024-02-19

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Primary DI, Brand, Company table
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