# K082191: Cardiomems Endosure S2 Pressure Sensor with Delivery System, Model S2-2080

- Pathway: 510(k) (Abbreviated)
- Applicant: Cardiomems, Inc.
- Decided: Aug 19, 2008 after 15 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 its predicate without a number.
- (no number) CardioMEMS EndoSure Wireless AAA Pressure Measurement System: named in the summary without a submission number

## Indications for use
The CardioMEMS EndoSure s2 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. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.

Source page: https://510kreport.com/device/K082191
Methodology: https://510kreport.com/methodology