# K032613: Temporary Transvenous Pacemaker Placement Assist Device

- Pathway: 510(k) (Traditional)
- Applicant: Peter M. Rothenberg, M.D.
- Decided: Nov 20, 2003 after 87 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 2 cite it directly.
6 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K093775: Evguide Tip Location System (2010), 34 descendants of its own
- K140799: Celerity Sysyem (2014), 13 descendants of its own
- K103255: Vascular Positioning System TM (VPS TM System) Stylet (2011), 10 descendants of its own
- K142889: Celerity PICC Tip Confirmation System (2015), 8 descendants of its own
- K112744: Sapiens Tip Confirmation System (2011), 7 descendants of its own

## Indications for use
This device is designed to connect an intravascular electrode to a monitor through a standard EKG patient lead for the purpose of displaying an intravascular signal in real time. Only the black pinjack is "active". The red pinjack is electrically blind, and designed to isolate the proximal electrode from inadvertent stimulation.

Source page: https://510kreport.com/device/K032613
Methodology: https://510kreport.com/methodology