Reprocessed Supreme Diagnostic Electrophysiology Catheters
by Innovative Health LLC 510(k)
Active
510(k) K161769
Overview
Reprocessed Supreme Diagnostic Electrophysiology Catheters are catheters, electrode recording, or probe, electrode recording devices used for diagnostic electrophysiology procedures. They are classified as Class II medical devices under product code DRF and regulation number 870.1220.
These devices are reprocessed for single use and are supplied by Innovative Health, LLC. They are subject to federal law restricting sale to or on the order of a physician. Authorizations include FDA 510(k) clearance K161769, determined to be substantially equivalent.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161769 | Date6 Dec 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRF
- FDA applicant
- Innovative Health, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1220
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Innovative Health, LLC.
Questions
What is the intended use of Reprocessed Supreme Diagnostic Electrophysiology Catheters?
These catheters are used for diagnostic electrophysiology procedures as electrode recording devices or probes, enabling the acquisition of electrical signals from cardiac tissue to assess heart rhythm and conduction pathways.
How are Reprocessed Supreme Diagnostic Electrophysiology Catheters supplied and for what purpose?
They are reprocessed for single use and supplied by Innovative Health, LLC, meaning each device is cleaned, tested, and repackaged after prior use to be used only once per patient to ensure safety and performance.
What regulatory authorization covers Reprocessed Supreme Diagnostic Electrophysiology Catheters?
These devices have FDA 510(k) clearance under K161769, which determined them to be substantially equivalent to a legally marketed predicate device, allowing their commercial distribution in the United States.