# K012678: Reprocessed Sealed Electrophysiology Diagnostic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Aug 14, 2002 after 365 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 8.
- K981642: Stablemapr Steerable Intracardiac Catheters, Medtronic Cardiorhythm (1998) Summary page 8.
- (no number) Bard Intracardiac Electrode Catheter: named in the summary without a submission number
- (no number) original manufacturer's 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 8.

## 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 Sealed 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/K012678
Methodology: https://510kreport.com/methodology