CardioMEMS Endosure Wireless AAA Pressure Measurement System, Model ADS-1001
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070448 FDA 510(k)
- FDA Product Code
- NQH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2855 FDA 510(k)
- Regulation Number
- 870.2855 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CardioMEMS Endosure Wireless AAA Pressure Measurement System, Model ADS-1001, is an implantable wireless pressure sensor classified as a pressure sensor for aneurysm monitoring. It is designed to measure intrasac pressure within abdominal aortic aneurysms (AAA) during and following endovascular repair procedures. This device aids in assessing the integrity of endovascular grafts by detecting potential endoleaks, which are leaks around the implanted stent graft. Its wireless functionality enables real-time pressure monitoring without the need for direct electrical connections.
This system is supplied as a sterile, single-use device intended for intraoperative use during endovascular AAA repair. It is regulated under FDA 510(k) clearance (K070448) and falls under the cardiovascular specialty category, classified as a Class II device. The sensor is implanted within the aneurysm sac to continuously monitor pressure, providing critical data to guide clinical decisions. Proper storage and handling per manufacturer instructions are required to maintain sterility and functionality prior to use.
Frequently asked questions
What is the CardioMEMS ADS-1001 used for?
The CardioMEMS ADS-1001 is an implantable wireless pressure sensor designed specifically for monitoring intrasac pressure within abdominal aortic aneurysms (AAA). It is used during and after endovascular repair procedures to assess the integrity of endovascular grafts by detecting endoleaks—leaks around the stent graft—which could compromise treatment outcomes. Continuous wireless monitoring provides critical data to guide clinical decisions without requiring direct electrical connections.
How is the CardioMEMS ADS-1001 supplied and prepared for use?
The CardioMEMS ADS-1001 is supplied as a sterile, single-use device intended exclusively for intraoperative use during endovascular AAA repair. It must be handled and stored according to the manufacturer’s instructions to preserve sterility and functionality. Since it is single-use, each device is intended for one-time implantation and subsequent monitoring, ensuring no risk of cross-contamination or reuse-related complications.
Is the CardioMEMS ADS-1001 reusable or single-use?
The CardioMEMS ADS-1001 is explicitly designed as a single-use device. This classification ensures patient safety by eliminating the risk of contamination or degradation from repeated sterilization or reuse. The wireless sensor is intended for one-time implantation and continuous monitoring, after which it is discarded. Single-use devices also reduce the likelihood of device-related complications associated with reuse.
What regulatory pathway does the CardioMEMS ADS-1001 follow?
The CardioMEMS ADS-1001 is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K070448. It is classified as a Class II device under the cardiovascular specialty category and falls under the product code NQH for aneurysm-related sensors. The device was determined to be substantially equivalent to a predicate device, allowing it to enter the market with the abbreviated 510(k) pathway. This classification reflects its role as a pressure sensor for aneurysm monitoring.
How is the sensor implanted and what does it measure?
The CardioMEMS ADS-1001 sensor is implanted directly within the aneurysm sac during endovascular repair. Once positioned, it continuously measures intrasac pressure in real-time, providing critical data on the pressure dynamics within the aneurysm. This monitoring helps clinicians detect endoleaks—unintended leaks around the endovascular graft—which could lead to aneurysm rupture or other complications. The wireless functionality allows for remote data transmission without the need for invasive connections, enabling ongoing assessment post-procedure.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cardiomems Endosure Wireless Aaa Pressure Measurement System, Model Ads ..., Cardiomems Endosure Pressure Sensor With Delivery System, Model Ads ..., Cardiomems Endosure Wireless Aaa Pressure Measurement System, Model Ads ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070448 | Class II | Active |
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Manufacturer
- Manufacturer
- Cardiomems, Inc.
Sources (1)
- FDA 510(k) K070448 24 fields · synced Oct 6, 2026