FDA.reportPublic FDA data

Cardio Flow Peripheral Guide Wire

Primary DI
00850040691023
Brand
Cardio Flow Peripheral Guide Wire
Company
Cardio Flow, Inc.
Model
GW1001
Device description
Cardio Flow Peripheral Guide Wire Guidewire, 325 CM
Published
2024-06-21
Public version status
New
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
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213834000Cardio Flow Peripheral Guide WireCardio Flow Inc.,2022-03-18DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040691016PackageGS15In Commercial Distribution
00850040691023PackageGS11In Commercial Distribution
00850040691009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040691016008500406910168500406910160850040691016
00850040691023008500406910238500406910230850040691023
00850040691009008500406910098500406910090850040691009

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Length325Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-294-5517customerservice@cardioflow.net

Regulatory Flags#

DUNS number
080505958
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040691009Cardio Flow Peripheral Guide WireGW10012024-06-21
00850040691030FreedomFlow Orbital Circumferential Atherectomy SystemH60012024-06-21
00850040691054FreedomFlow Orbital Circumferential Atherectomy SystemH60022024-06-21
00850040691085FreedomFlow Orbital Circumferential Atherectomy SystemH60042024-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001030638335 Helix GuidewirePIRAEUS MEDICAL INC.DQX2026-10-30
30801902124921ARROWTELEFLEX INCORPORATEDDQX2026-10-13
07540184010127OptoMonitorOpsens IncDQX2026-09-30
07540184020027OptoMonitorOpsens IncDQX2026-09-30
07540184020034OptoMOnitorOpsens IncDQX2026-09-30
07540184020041OptoMonitorOpsens IncDQX2026-09-30
07540184020058OptoMonitorOpsens IncDQX2026-09-30
07540184020065OptoMonitorOpsens IncDQX2026-09-30
07540184020072OptoMonitorOpsens IncDQX2026-09-30
00818075011261AristotleSCIENTIA VASCULAR LLCDQX2026-09-21
10801902226614ARROWTELEFLEX INCORPORATEDDQX2026-08-28
00884450529300SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529713SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529829SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450590010SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450631928InQwire® AmplatzMerit Medical Systems, Inc.DQX2026-08-21
00884450731789InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00884450739709InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQX2026-02-24
00818075010233AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010240AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010257AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010264AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
10801902210637ARROWTELEFLEX INCORPORATEDDQX2023-06-21
10801902202984ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902203073ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210583ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210590ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210613ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210620ARROWTELEFLEX INCORPORATEDDQX2023-06-06