Identity
- Trade Name
- Zebra FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- AC6074-115-20 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- AC6074-115-20 FDA UDI
- Primary DI / UDI-DI
- 00857545008202 FDA UDI
- 510(k) Number
- K240746 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vascular guide-catheter, single-use
Zebra by Q’Apel Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K240746 also covers:
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
- Zebra — QApel Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Q’Apel Medical, Inc.
Sources (1)
- FDA UDI 61e53d47-da8b-4d08-85e5-47cc7e81a6e2 35 fields · synced Jun 1, 2026