# K051137: Techdevice Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Techdevice Corporation
- Decided: Feb 24, 2006 after 296 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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 K021721 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021721: Equalizer Balloon Catheter, Boston Scientific Corp (2002) Summary page 1.

## Most influential descendants
- K094048: Percupro Messenger Balloon Catheter (2011), 0 descendants of its own

## Recalls of this device
- Jul 16, 2010 · Not classified · Z-0322-2011: Updated Instructions for Use- HeartStart MRx monitor/defibrillator. The update provides more detailed information on: " Default ECG Lead Behavior " Synchronized Cardioversion using External Paddles

## Indications for use
The TechDevice Percutaneous Occlusion Balloon Catheter is for temporary vessel occlusion, where the stoppage of blood flow is desirable. This device is not indicated for neuro, or cardiac use

Source page: https://510kreport.com/device/K051137
Methodology: https://510kreport.com/methodology