Veripath Peripheral Guiding Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994229 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Veripath Peripheral Guiding Catheter is a single-lumen catheter designed to provide a pathway for interventional and diagnostic devices into the peripheral vasculature. It includes an inner catheter to assist with introduction and withdrawal. The device is used by physicians during vascular procedures to facilitate the navigation and placement of interventional devices.
The Veripath Peripheral Guiding Catheter is intended for use in procedures requiring precise catheter guidance, such as venous stenting. It is supplied as a single-use device and requires appropriate storage conditions. The device has FDA 510(k) clearance with the number K994229.
Frequently asked questions
What is the Veripath Peripheral Guiding Catheter used for?
The Veripath Peripheral Guiding Catheter is designed to provide a pathway for interventional and diagnostic devices into the peripheral vasculature. It is used by physicians during vascular procedures to facilitate navigation and placement of other devices, particularly in procedures requiring precise guidance such as venous stenting.
Is the Veripath Peripheral Guiding Catheter single-use or reusable?
The Veripath Peripheral Guiding Catheter is supplied as a single-use device. It includes an inner catheter to assist with introduction and withdrawal during procedures. After use, the device should be discarded according to medical waste disposal protocols.
What regulatory clearance does the Veripath Peripheral Guiding Catheter have?
The Veripath Peripheral Guiding Catheter has FDA 510(k) clearance with the number K994229. It was determined to be substantially equivalent to predicate devices and received special clearance type designation from the Cardiovascular advisory committee.
How should the Veripath Peripheral Guiding Catheter be stored?
The Veripath Peripheral Guiding Catheter requires appropriate storage conditions to maintain its integrity. While specific storage parameters aren't detailed in the provided information, medical devices of this type typically should be stored in a clean, dry environment at room temperature, away from direct sunlight and extreme temperatures, and in their original packaging until use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Veripath Peripheral Guiding Catheter - Advanced Cardiovascular Systems ..., VERIPATH PERIPHERAL GUIDING CATHETER (K994229) — FDA 510 (k) | Innolitics, K994229 FDA 510 (k) - VERIPATH PERIPHERAL GUIDING CATHETER, K994229 FDA 510 (k) - VERIPATH PERIPHERAL GUIDING CATHETER
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994229 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K994229 24 fields · synced Sep 21, 2026