FDA.reportPublic FDA data

87 NeuGlide+ Catheter

Primary DI
00860015527776
Brand
87 NeuGlide+ Catheter
Company
PIRAEUS MEDICAL INC.
Model
100650-006
Catalog number
100650-006
Device description
The 87 NeuGlide+ Catheter (100650-006) has an inner diameter of 0.087" (6F compatible), a maximum outer diameter of 0.100", and a working length of 95 cm.
Published
2026-10-29
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

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K24097100087 NeuGlide CatheterPiraeus Medical2024-12-06QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015527776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015527776008600155277768600155277760860015527776

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.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327682427Excelsior ReachStryker CorporationDQY2026-10-29
07613327682427Excelsior ReachStryker CorporationQJP2026-10-29
07613327682434Excelsior ReachStryker CorporationQJP2026-10-29
07613327682434Excelsior ReachStryker CorporationDQY2026-10-29
07613327682441Excelsior ReachStryker CorporationDQY2026-10-29
07613327682441Excelsior ReachStryker CorporationQJP2026-10-29
07613327682458Excelsior ReachStryker CorporationQJP2026-10-29
07613327682458Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationQJP2026-10-29
07613327682496Excelsior ReachStryker CorporationDQY2026-10-29
07613327682496Excelsior ReachStryker CorporationQJP2026-10-29
07613327682526Excelsior ReachStryker CorporationQJP2026-10-29
07613327682526Excelsior ReachStryker CorporationDQY2026-10-29
07613327682571Excelsior ReachStryker CorporationQJP2026-10-29
07613327682571Excelsior ReachStryker CorporationDQY2026-10-29
07613327694796Broadway 8Stryker CorporationQJP2026-10-27
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
00850085183002FreeClimb 46 Catheter x125cmROUTE 92 MEDICALQJP2026-10-12
00850085183019FreeClimb 46 Catheter x143cmROUTE 92 MEDICALQJP2026-10-12
00850085183026FreeClimb 46 Catheter x125cm with Tenzing 4ROUTE 92 MEDICALQJP2026-10-12
00850085183033FreeClimb 46 Catheter x143 cm with Tenzing 4ROUTE 92 MEDICALQJP2026-10-12
00850085183040Tenzing 4 Delivery CatheterROUTE 92 MEDICALQJP2026-10-12
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
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00810068568998Next Generation 088 CatheterBALT USA LLCQJP2026-10-01
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