FDA.reportPublic FDA data

35 Helix Guidewire

Primary DI
00860010306383
Brand
35 Helix Guidewire
Company
PIRAEUS MEDICAL INC.
Model
100590
Catalog number
100590
Device description
The 35 Helix Guidewire (100590) has a maximum diameter of 0.035", a length of 180 cm, a 25 cm flex length, 80 cm of hydrophilic coating, and a round curve tip shape.
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
MOFGuide, Wire, Catheter, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260751000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K26075100035 Helix GuidewirePiraeus Medical, Inc.2026-08-27MOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010306383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010306383008600103063838600103063830860010306383

Regulatory Flags#

DUNS number
128420207
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
0086001552777687 NeuGlide+ Catheter100650-006100650-0062026-10-29
0086001552773870 NeuGlide Catheter100898-002100898-0022026-10-06
0086001552774570 NeuGlide Catheter100898-003100898-0032026-10-06
0086001552775287 NeuGlide Catheter103577-005103577-0052026-08-06
0086001552776987 NeuGlide Catheter103577-006103577-0062026-08-06
0086001552770787 NeuGlide+ Catheter100650-004100650-0042026-05-18
0086001552771487 NeuGlide+ Catheter100650-005100650-0052026-05-18
0086001030636987 NeuGlide+ Catheter100650-002100650-0022026-02-02
0086001030637687 NeuGlide+ Catheter100650-003100650-0032026-02-02
0086001030632187 NeuGlide Catheter103577-004103577-0042025-07-15
0086001030633893 NeuFlex Catheter100148-001100148-0012025-06-18
0086001030634593 NeuFlex Catheter100148-002100148-0022025-06-18
0086001030630787 NeuGlide Catheter103577-001103577-0012025-01-02
0086001030631487 NeuGlide Catheter103577-002103577-0022025-01-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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 LLCMOF2026-09-21
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
00818075010233AristotleSCIENTIA VASCULAR LLCMOF2023-09-25
00818075010240AristotleSCIENTIA VASCULAR LLCMOF2023-09-25
00818075010240AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010257AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010257AristotleSCIENTIA VASCULAR LLCMOF2023-09-25
00818075010264AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010264AristotleSCIENTIA VASCULAR LLCMOF2023-09-25
10801902202984ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902203073ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210583ARROWTELEFLEX INCORPORATEDDQX2023-06-06