FDA.reportPublic FDA data

87 NeuGlide+ Catheter

Primary DI
00860010306376
Brand
87 NeuGlide+ Catheter
Company
PIRAEUS MEDICAL INC.
Model
100650-003
Catalog number
100650-003
Device description
"The 87 NeuGlide+ Catheter (100650-003) has an inner diameter of 0.087"" (6F compatible), a maximum outer diameter of 0.100"", and a working length of 90 cm."
Published
2026-02-02
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

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
00860010306376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010306376008600103063768600103063760860010306376

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 (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
128420207
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0086001552770787 NeuGlide+ Catheter100650-004100650-0042026-05-18
0086001552771487 NeuGlide+ Catheter100650-005100650-0052026-05-18
0086001030636987 NeuGlide+ Catheter100650-002100650-0022026-02-02
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
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07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
00763000539351RebarMicro Therapeutics, Inc.QJP2022-02-27
07613327519372AXS VECTA 46Stryker CorporationQJP2021-12-17
07613327313956Trevo Trak 21Stryker CorporationQJP2020-04-17
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