Product code NQH— Cardiovascular
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
- Classification name
- Sensor, Pressure, Aneurysm, Implantable
- Device class
- Class 2
- Regulation
- 21 CFR 870.2855
- Advisory panel
- Cardiovascular
- Total cleared
- 5
- First cleared
- Most recent
FDA classification definition
“This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.”
Market context for product code NQH
FDA has cleared devices under product code NQH between 2005 and 2008, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2008
- 2007
- 2006
- 2005
Top applicants under product code NQH
Recent clearances under product code NQH
- K082191 — CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
- K070680 — CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080
- K070448 — CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
- K061046 — CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001
- DEN050006 — CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.