Cardiomems Endosure S2 Pressure Sensor with Delivery System, Model S2-2080
FDA 510(k) K082191 · Cardiomems, Inc.
510(k) numberK082191
Submission
- Device name
- Cardiomems Endosure S2 Pressure Sensor with Delivery System, Model S2-2080
- Applicant
- Cardiomems, Inc.
Atlanta, GA, US - Received
- August 4, 2008
- Decision date
- August 19, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQH – Sensor, Pressure, Aneurysm, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2855
- Specialty
- Cardiovascular
- Implant
- Yes
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
Other 510(k)s with product code NQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070680 | Cardiomems Endosure S2 14F Wireless Aaa Pressure Measurement System, Model# S2-2080NQH · Special | Cardiomems, Inc. | 04/05/2007SE |
| K070448 | Cardiomems Endosure Wireless Aaa Pressure Measurement System, Model ADS-1001NQH · Abbreviated | Cardiomems, Inc. | 03/15/2007SE |
| K061046 | Cardiomems Endosure Pressure Sensor with Delivery System, Model ADS-1001 and…NQH · Traditional | Cardiomems, Inc. | 10/12/2006SE |
More from Cardiomems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070680 | Cardiomems Endosure S2 14F Wireless Aaa Pressure Measurement System, Model# S2-2080NQH · Special | 04/05/2007SE |
| K070448 | Cardiomems Endosure Wireless Aaa Pressure Measurement System, Model ADS-1001NQH · Abbreviated | 03/15/2007SE |
| K061046 | Cardiomems Endosure Pressure Sensor with Delivery System, Model ADS-1001 and…NQH · Traditional | 10/12/2006SE |
Questions and answers
When was Cardiomems Endosure S2 Pressure Sensor with Delivery System, Model S2-2080 cleared by the FDA?
Cardiomems Endosure S2 Pressure Sensor with Delivery System, Model S2-2080 (K082191) received a 510(k) decision of Substantially Equivalent on August 19, 2008, 15 days after the submission was received.
What is the product code of K082191?
The FDA product code is NQH – Sensor, Pressure, Aneurysm, Implantable, a Class II (moderate risk) device regulated under 21 CFR 870.2855.