Quinton Mahurkar Catheters W/Vitacuff
510(k) K895440
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895440 | Date29 Nov 1989 | 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- Withdrawn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, 21 Sep 2026
The Quinton Mahurkar Catheters with Vitacuff are specialized catheters designed for venous access, often used in patients requiring dialysis. The Vitacuff feature helps reduce infection risk by providing a barrier at the catheter exit site. These catheters are inserted into large veins to facilitate efficient blood flow during dialysis sessions.
The Quinton Mahurkar Catheters w Vitacuff are supplied with FDA 510(k) clearance, classified as a cardiovascular device. They are percutaneous catheters introduced into a vein or artery through the skin using a dilator and a sheath or guide wire. The device has a product code of DQY and was cleared on November 29, 1989.
Other devices from Quinton, Inc.
Questions
AI-generated answers, 21 Sep 2026
What are Quinton Mahurkar Catheters with Vitacuff used for?
They are used for venous access in patients requiring dialysis, facilitating efficient blood flow during dialysis sessions by reducing infection risk.
How are the catheters inserted?
They are percutaneously introduced into a vein or artery through the skin using a dilator and a sheath or guide wire.
What is the Vitacuff feature?
The Vitacuff feature provides a barrier at the catheter exit site, helping to reduce the risk of infection.