Right Atrial Catheters
by Akcess Medical Products, Inc.
510(k) K911333
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911333 | Date23 Sep 1991 | 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- Withdrawn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
Right atrial catheters are medical devices designed for central venous access, specifically for placement in the right atrium of the heart. They are used to monitor central venous pressure, administer fluids or medications, and facilitate blood sampling.
These catheters are supplied by Akcess Medical Products, Inc. and were cleared under FDA 510(k) K911333 as substantially equivalent to a predicate device. The device is intended for use in clinical settings and is subject to standard regulatory controls for cardiovascular devices under product code DQY.
Other devices from Akcess Medical Products, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the intended use of the right atrial catheters from Akcess Medical?
The right atrial catheters are designed for central venous access in the right atrium to monitor central venous pressure, administer fluids or medications, and facilitate blood sampling in clinical settings.
How were the Akcess Medical right atrial catheters cleared for market?
The device was cleared under FDA 510(k) K911333 as substantially equivalent to a predicate device, meaning it met the requirements for substantial equivalence through the traditional 510(k) pathway.
Who manufactures the right atrial catheters referenced in K911333?
Akcess Medical Products, Inc., located at 789 Jersey Ave., New Brunswick, NJ 08901, is the manufacturer and applicant for the right atrial catheters cleared under FDA 510(k) K911333.