Identity
- Trade Name
- Quick-Access™ FDA UDI
- Generic Name
- Interventional radiology percutaneous-access kit, single-use FDA UDI
- Device Name
- Quick-Access™ Needle Holder FDA UDI
- Model / Reference
- 519-005AA FDA UDI
- Description
- Quick-Access™ Needle Holder FDA UDI
Identifiers
- Catalog Number
- 519-005 FDA UDI
- Primary DI / UDI-DI
- 00813132020736 FDA UDI
- 510(k) Number
- K112887 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Interventional radiology percutaneous-access kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
No
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
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Interventional radiology percutaneous-access kit, single-use
Quick-Access™ by Spectranetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interventional radiology percutaneous-access kit, single-use.
- Access Needle — Mermaid Medical A/S · Class I
- EXTesia — Curatia Medical Limited · Class IIa
- SWL-Pathfinder — SWL Medizin GmbH · Class III
- Mini Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- EXTesia — Curatia Medical Limited · Class IIa
- Introducer Set — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- EXTesia — Curatia Medical Limited · Class IIa
- Shun Guider — Shunmei Medical Co.,Ltd · Class IIa
Cleared under the same submission
K112887 also covers:
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
- Spectranetics Corporation
Sources (1)
- FDA UDI 05e2002c-fcb8-49fc-9d6c-2d72c8b20177 37 fields · synced May 30, 2026