# K070680: Cardiomems Endosure S2 14F Wireless Aaa Pressure Measurement System, Model# S2-2080

- Pathway: 510(k) (Special)
- Applicant: Cardiomems, Inc.
- Decided: Apr 5, 2007 after 24 days
- Product code: NQH (Sensor, Pressure, Aneurysm, Implantable)
- Device class: 2
- Regulation: 21 CFR 870.2855
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks.

Source page: https://510kreport.com/device/K070680
Methodology: https://510kreport.com/methodology