# K051220: Reprocessed Deflectable Electrophysiology Diagnostic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jun 14, 2005 after 33 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SterilMed Reprocessed Deflectable Electrophysiology: named in the summary without a submission number

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0555-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
The SterilMed Reprocessed Electrophysiological Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac arrhythmias, and are used for electrophysiology mapping of cardiac structures during these evaluations.

Source page: https://510kreport.com/device/K051220
Methodology: https://510kreport.com/methodology