Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2855](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2855) → NQH — Sensor, Pressure, Aneurysm, Implantable

# NQH · Sensor, Pressure, Aneurysm, Implantable

_Cardiovascular · 21 CFR 870.2855 · Class 2_

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

## Overview

- **Product Code:** NQH
- **Device Name:** Sensor, Pressure, Aneurysm, Implantable
- **Regulation:** [21 CFR 870.2855](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2855)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Implant:** yes

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K082191](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/K082191.md) | CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 | Cardiomems, Inc. | Aug 19, 2008 | SESE |
| [K070680](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/K070680.md) | CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 | Cardiomems, Inc. | Apr 5, 2007 | SESE |
| [K070448](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/K070448.md) | CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 | Cardiomems, Inc. | Mar 15, 2007 | SESE |
| [K061046](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/K061046.md) | CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 | Cardiomems, Inc. | Oct 12, 2006 | SESE |
| [DEN050006](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/DEN050006.md) | CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM | Cardiomems, Inc. | Oct 28, 2005 | DENG |

## Top Applicants

- Cardiomems, Inc. — 5 clearances

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

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