Zebra

Primary DI
00857545008394
Brand
Zebra
Company
Q'APEL MEDICAL LLC
Model
AC6074-095
Catalog number
AC6074-095
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, 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
2026-03-05
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

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
00857545008394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857545008394008575450083948575450083940857545008394

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
020937374
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857545008011WalrusFG 00100-01BG8087-0902021-06-29
00857545008028WalrusFG 00100-02BG8087-0952021-06-29
008575450080806F ArmadilloFG 00735-052023-08-04
00857545008004WahooFG 00074SF7072-1052021-06-29
00857545008400ZebraAC6074-105AC6074-1052026-03-05
00857545008431ZebraAC7087-095AC7087-0952026-03-05
00857545008448ZebraAC7087-105AC7087-1052026-03-05
00857545008097072 Aspiration SystemFG 00806AP6072-1322023-10-11
00857545008103072 Aspiration SystemFG 00995APT-952023-10-11
00857545008127072 Aspiration SystemFG 01252APT6072-1322023-10-11
00857545008158ZebraAC6074-095-30AC6074-095-302025-01-03
00857545008165ZebraAC6074-105-30AC6074-105-302025-01-03
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

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