# K971775: Interim AV Shaped Temporary Pacing Catheter Model Int-AV610

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Control Systems, Inc.
- Decided: Dec 29, 1997 after 230 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
Longest line of descent: 1 generation back to K770214 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770214: Temp. Pervenous Lead W/Remote Anode, Cordis Corp. (1977) Summary page 1.

## Indications for use
INTERIM™ AV Temporary Pacing Catheters are indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chambers.

Source page: https://510kreport.com/device/K971775
Methodology: https://510kreport.com/methodology