Acs Powerbase Guilding Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K952205 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 ACS Powerbase Guiding Catheter is a specialized catheter designed to facilitate the placement of interventional devices within the vascular system. It provides support and stability for the passage of other catheters and instruments during procedures. The catheter's design allows for precise navigation through the vascular anatomy, making it an essential tool in complex interventions.
The ACS Powerbase Guiding Catheter is supplied by Advanced Cardiovascular Systems, Inc. and has received FDA 510(k) clearance with number K952205. It is classified under product code DQY and was reviewed by the Cardiovascular advisory committee. The device is intended for use in interventional procedures requiring vascular access and device guidance.
Frequently asked questions
What is the ACS Powerbase Guiding Catheter used for?
The ACS Powerbase Guiding Catheter is designed to facilitate the placement of interventional devices within the vascular system. It provides support and stability for the passage of other catheters and instruments during complex interventional procedures.
How is the ACS Powerbase Guiding Catheter supplied?
The ACS Powerbase Guiding Catheter is supplied by Advanced Cardiovascular Systems, Inc. It has received FDA 510(k) clearance with number K952205 and is classified under product code DQY.
Is the ACS Powerbase Guiding Catheter single-use or reusable?
The device data does not specify whether the ACS Powerbase Guiding Catheter is single-use or reusable. For proper usage instructions, please refer to the manufacturer's documentation or contact Advanced Cardiovascular Systems, Inc.
What regulatory approvals does the ACS Powerbase Guiding Catheter have?
The ACS Powerbase Guiding Catheter has received FDA 510(k) clearance with number K952205. It was reviewed by the Cardiovascular advisory committee and is classified under product code DQY.
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: ACS POWERBASE GUILDING CATHETER (K952205) — FDA 510 (k) | Innolitics, ACS Powerbase Guiding Catheter - Advanced Cardiovascular Systems | FDA ..., ACS POWERBASE GUILDING CATHETER 510(k) K952205 - FDA.report, ACS Powerbase TM Coronary Guiding Catheter - Advanced Cardiovascular ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K952205 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K952205 24 fields · synced Sep 25, 2026