# K012523: Reprocessed Electrophysiology Diagnostic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Aug 14, 2002 after 373 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
Longest line of descent: 1 generation back to K953768 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953768: Cordis Webster A20 Diagnostic Deflectable Tip Catheter, Cordis Webster, Inc. (1995) Summary page 1.
- K981642: Stablemapr Steerable Intracardiac Catheters, Medtronic Cardiorhythm (1998) Summary page 1.
- (no number) Bard Intracardiac Electrode Catheter: named in the summary without a submission number
- (no number) original manufacturers’ devices: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K912213: Bard Dynamic Tip Catheter. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## 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 Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.

Source page: https://510kreport.com/device/K012523
Methodology: https://510kreport.com/methodology