FDA.reportPublic FDA data

coraForce

Primary DI
00856492005708
Brand
coraForce
Company
REFLOW MEDICAL, INC.
Model
FRC14135US
Device description
Cora Force Torqueable Microcatheter 14x135cm
Published
2020-12-18
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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856492005708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856492005708008564920057088564920057080856492005708

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
Catheter Working Length0
Guidewire Diameter0

Contacts#

Phone, Email table
PhoneEmail
9494810399quality@reflowmedical.com

Regulatory Flags#

DUNS number
962545294
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
00850025525022Spex LPSLP35135US2021-06-10
00850025525039Spex LPSLP35150US2021-06-10
00850025525213SINCSINC35090US2024-02-19
00850025525220SINCSINC35135US2024-02-19
00850025525060SPEX35SPN35050US2021-09-23
00850025525077SPEX35SPN35090US2021-09-23
00850025525084SPEX35SPN35135US2021-09-23
00850025525091SPEX35SPN35150US2021-09-23
00850025525015Spex LPSLP35090US2021-06-10
00850025525046coraCrossCRX14135US2021-06-03
00850025525053coraCrossCRX14150US2021-06-03
00856492005692coraForceFRC14150US2020-12-18
00856492005715coraFlexFLX14135US2020-12-18
00856492005722coraFlexFLX14150US2020-12-18
00856492005630Spex LPSLP14090US2020-05-08
00856492005647Spex LPSLP14135US2020-05-08
00856492005654Spex LPSLP14150US2020-05-08
00856492005661Spex LPSLP18090US2020-05-08
00856492005678Spex LPSLP18135US2020-05-08
00856492005685Spex LPSLP18150US2020-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
00191506019563Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019587Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
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00191506019709Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019723Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019747Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019761Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019785Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019808Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019822Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019846Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019860Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019884Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00389701012896R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
00389701012902R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
10801902215502ARROWTELEFLEX INCORPORATEDDQY2023-07-10
10801902215267ARROWTELEFLEX INCORPORATEDDQY2023-07-07