FDA.reportPublic FDA data

Spur Peripheral Retrievable Stent System

Primary DI
00850025525169
Brand
Spur Peripheral Retrievable Stent System
Company
REFLOW MEDICAL, INC.
Model
BSPUR365135US
Device description
Peripheral Retrievable Stent System; 3mm x 65mm, catheter shaft length 135cm
Published
2025-06-06
Public version status
New
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
SEUPeripheral Temporary And Retrievable Stent System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SEUPeripheral Temporary And Retrievable Stent SystemCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240048000Spur Peripheral Retrievable Stent SystemReflow Medical, Inc.2025-05-29SEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850025525169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025525169008500255251698500255251690850025525169

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery stent, bare-metalA non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Shaft Length135Centimeter
Stent Diameter3Millimeter
Stent Length65Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9494810399quality@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
00850025525176Spur Peripheral Retrievable Stent SystemBSPUR460135US2025-06-06
00850025525213SINCSINC35090US2024-02-19
00850025525220SINCSINC35135US2024-02-19
00850025525022Spex LPSLP35135US2021-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025525176Spur Peripheral Retrievable Stent SystemREFLOW MEDICAL, INC.SEU2025-06-06