← Product Code [NQH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH) · K070680

# CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 (K070680)

_Cardiomems, Inc. · NQH · Apr 5, 2007 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/K070680

## Device Facts

- **Applicant:** Cardiomems, Inc.
- **Product Code:** [NQH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH.md)
- **Decision Date:** Apr 5, 2007
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.2855
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## 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.

## 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.

## Regulatory 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.

## Submission Summary (Full Text)

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## INDICATIONS FOR USE

510(k) Number (if known): K070680

CardioMEMS EndoSure™ s2 14F Wireless AAA Device Name: Pressure Measurement System

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.

______________________________________________________________________________________________________________________________________________________________________________ Prescription Use X (Part 21 CRF 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE---- CONTINUE ON ANOTHER PAGE IF NEEDED)

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/K070680](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/K070680)

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