7 French Dual Lumen Com Cent Vein Cath Sys
by Cardio-Vascular Innovations, Inc.
510(k) K852791
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852791 | Date5 Nov 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The 7 French Dual Lumen Central Venous Catheter System is a dual-lumen catheter designed for central venous access. It is classified as a central venous catheter under the FDA’s product code DQY, intended for insertion into large central veins such as the subclavian or internal jugular vein. The device facilitates simultaneous administration of medications, fluids, or monitoring of central venous pressure through its two distinct lumens. Its dual-lumen design enhances procedural flexibility for both short- and long-term vascular access applications.
This catheter system is supplied as a sterile, single-use device and is regulated under the FDA’s 510(k) clearance process (K852791). It is intended for use in clinical settings where central venous access is required, such as intensive care units, operating rooms, or procedural suites. The 7 French gauge size is specified for compatibility with standard venous access procedures. Storage and handling must adhere to sterile medical device protocols to ensure patient safety and device integrity.
Other devices from Cardio-Vascular Innovations, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the 7 French Dual Lumen Central Venous Catheter System used for?
This catheter system is designed for central venous access, allowing healthcare providers to insert it into large veins like the subclavian or internal jugular vein. Its dual-lumen design enables simultaneous administration of medications or fluids while also monitoring central venous pressure, making it ideal for short- and long-term vascular access in intensive care units, operating rooms, or procedural suites.
Is the 7 French Dual Lumen Central Venous Catheter System single-use or reusable?
The device is supplied as a sterile, single-use catheter system. This ensures patient safety by preventing contamination and maintaining device integrity, which is critical for sterile medical procedures.
What is the gauge size of this catheter, and why is it specified?
The catheter is specified as 7 French in gauge size, which is a standard measurement for venous access procedures. This size balances compatibility with common venous access techniques while providing adequate lumen diameter for effective fluid administration and pressure monitoring.
How should the 7 French Dual Lumen Central Venous Catheter System be stored?
The catheter must be stored according to sterile medical device protocols to preserve its integrity and sterility. This includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened until immediate use.
What regulatory pathway does this device follow?
The 7 French Dual Lumen Central Venous Catheter System is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K852791. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for central venous catheters.