Sensor, Pressure, Aneurysm, Implantable
The implantable aneurysm pressure sensor is a cardiovascular implant designed to measure pressure within the aneurysm sac during and after endovascular repair procedures, allowing long-term post-procedural monitoring of aneurysm pressurization. It is classified as FDA Class 2 under regulation 870.2855 in the Cardiovascular specialty, requiring 510(k) clearance, and carries an implant flag. Product code NQH is not eligible for third-party review.
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Basic Information
- Product Code
- NQH
- Device Class
- FDA class 2
- Regulation Number
- 870.2855
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K082191 | CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 | Aug 19, 2008 | Substantially Equivalent | Cardiomems, Inc. |
| K070680 | CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 | Apr 05, 2007 | Substantially Equivalent | Cardiomems, Inc. |
| K070448 | CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 | Mar 15, 2007 | Substantially Equivalent | Cardiomems, Inc. |
| K061046 | CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 | Oct 12, 2006 | Substantially Equivalent | Cardiomems, Inc. |
| DEN050006 | CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM | Oct 28, 2005 | Unknown | Cardiomems, Inc. |