# K955829: Safpace System

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 18, 1997 after 693 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 K803058 (1981). 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)
- K803058: Swan-Ganz Flow-Directed Multipur. Cath., American Edwards Laboratories (1981) Summary page 1.
- K822806: Balloon Wedge Pressure, Angiographic, Nova Medical Specialties (1982) Summary page 1.
- (no number) VastoStim: named in the summary without a submission number

## Indications for use
The catheter is designed for accurate measurement of cardiac output, direct measurement of pulmonary artery blood temperature, pressure monitoring, and infusing solutions. The SafPace™ catheter may also be used for temporary ventricular pacing. The V-Pacing Wire is used for temporary ventricular pacing only when used with the SafPace™ catheter. The wire may also be used for intraventricular ECG monitoring.

Source page: https://510kreport.com/device/K955829
Methodology: https://510kreport.com/methodology