CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080
Device Facts
| Record ID | K070680 |
|---|---|
| Device Name | CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 |
| Applicant | Cardiomems, Inc. |
| Product Code | NQH · Cardiovascular |
| Decision Date | Apr 5, 2007 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.2855 |
| Device Class | Class 2 |
Intended 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.
Device Story
Wireless pressure measurement system; monitors intrasac pressure during endovascular AAA repair. Device provides real-time pressure data to assist surgeons in identifying intraoperative endoleaks. Used in OR setting by vascular surgeons. System facilitates immediate clinical assessment of aneurysm sac exclusion; aids in decision-making regarding need for secondary interventions during primary repair procedure. Benefits include improved intraoperative monitoring of aneurysm sac hemodynamics.
Technological Characteristics
Wireless pressure sensor; 14F delivery system; intrasac pressure measurement capability.
Indications for Use
Indicated for patients undergoing endovascular abdominal aortic aneurysm (AAA) repair. Used for intraoperative intrasac pressure measurement and adjunctive detection of endoleaks.
Regulatory Classification
Identification
Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See § 870.1 (e) for the availability of this guidance document.
Related Devices
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- K070448 — CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 · Cardiomems, Inc. · Mar 15, 2007
- K061046 — CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 · Cardiomems, Inc. · Oct 12, 2006
- K141275 — ENDOPHYS PRESSURE SENSING SHEATH KIT · Endophys, Inc. · Jan 7, 2015
