FDA.reportPublic FDA data

Zebra

Primary DI
00857545008165
Brand
Zebra
Company
Q'APEL MEDICAL LLC
Model
AC6074-105-30
Catalog number
AC6074-105-30
Device description
The Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.
Published
2025-01-03
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

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240746000Neurovascular Access System FamilyQ'Apel Medical, Inc.2024-11-20QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857545008165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857545008165008575450081658575450081650857545008165

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
020937374
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857545008394ZebraAC6074-095AC6074-0952026-03-05
00857545008400ZebraAC6074-105AC6074-1052026-03-05
00857545008431ZebraAC7087-095AC7087-0952026-03-05
00857545008448ZebraAC7087-105AC7087-1052026-03-05
00857545008158ZebraAC6074-095-30AC6074-095-302025-01-03
00857545008172ZebraAC6074-115-30AC6074-115-302025-01-03
00857545008189ZebraAC6074-095-20AC6074-095-202025-01-03
00857545008196ZebraAC6074-105-20AC6074-105-202025-01-03
00857545008202ZebraAC6074-115-20AC6074-115-202025-01-03
00857545008219ZebraAC7087-095-20-SAC7087-095-20-S2025-01-03
00857545008226ZebraAC7087-105-20-SAC7087-105-20-S2025-01-03
00857545008233ZebraAC7087-095-20-BAC7087-095-20-B2025-01-03
00857545008240ZebraAC7087-105-20-BAC7087-105-20-B2025-01-03
00857545008257ZebraAC6074-080-30AC6074-080-302025-01-03
00857545008264ZebraAC6074-080-20AC6074-080-202025-01-03
00857545008271ZebraAC7087-080-20-SAC7087-080-20-S2025-01-03
00857545008288ZebraAC7087-080-20-BAC7087-080-20-B2025-01-03
008575450080806F ArmadilloFG 00735-052023-08-04
00857545008042ArmadilloFG 00464-05SF7072-105-22-302022-01-16
00857545008059ArmadilloFG 00464-04SF7072-95-22-302022-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00857545008158ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008172ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008189ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008196ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008202ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008219ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008226ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008233ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008240ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008257ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008264ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008271ZebraQ'APEL MEDICAL LLCDQY2025-01-03