Elecath Percutaneous Left Atrial Cannulation Set
510(k) K854511
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854511 | Date10 Feb 1986 | 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- Withdrawn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
- DQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Elecath Percutaneous Left Atrial Cannulation Set is a medical device designed for percutaneous cannulation of the left atrium. It is classified under the regulatory category of wire, guide, catheter, and falls under the medical specialty of cardiovascular.
The device is supplied as a single-use item and is intended for use in clinical settings. It is not specified as MRI safe, and no storage or sizing details are provided. The device has received FDA 510(k) clearance under K854511, with a decision date of February 10, 1986.