# K061046: Cardiomems Endosure Pressure Sensor with Delivery System, Model Ads-1001 and Interrogator, Model Ems 5001

- Pathway: 510(k) (Traditional)
- Applicant: Cardiomems, Inc.
- Decided: Oct 12, 2006 after 181 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 EndoSureTM Wireless AAA Pressure Measurement System: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K061046
Methodology: https://510kreport.com/methodology