# K094048: Percupro Messenger Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cardiosolutions, Inc.
- Decided: Jul 14, 2011 after 560 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021721 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051137: Techdevice Occlusion Balloon Catheter, Techdevice Corporation (2006) Summary page 1.
- K961999: Schneider Guider Softip Guiding Catheters, Boston Scientific Scimed, Inc. (1996) Summary page 2.
- K010853: Guider Softip Guiding Catheter XF 5F, Boston Scientific, Target (2001) Summary page 1.
- K083384: Thermodilution Catheter, Biosensors Intl. Pte., Ltd. (2010). Cleared while this submission was under review Summary page 2.

## Indications for use
The Percu-ProTM Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.

Source page: https://510kreport.com/device/K094048
Methodology: https://510kreport.com/methodology