(76 days)
Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.
Endoaortic Clamp (Catalog Number 02055)
This document does not describe acceptance criteria or a study that proves a device meets them. Instead, it is a 510(k) summary for a medical device (Endoaortic Clamp) and contains the following information:
- Applicant Information: Heartport, Inc.
- Device Information:
- Trade Name: Endoaortic Clamp (Catalog Number 02055)
- Common Name: Endoaortic Clamp Catheter
- Classification Name: Cardiopulmonary bypass vascular catheter
- Equivalent Devices: Heartport Endoaortic Clamp (Catalog Number 01055)
- Intended Use: Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.
- Comparison To Predicate Devices: The new device is a preassembled version of the predicate device with necessary accessories in one sterile package.
- Non-clinical Test Results: States that performance testing demonstrated with 95% confidence that the device meets or exceeds Heartport, Inc. performance standards.
- Test Conclusions: States that performance testing demonstrated the device will function safely and efficaciously, meeting anticipated clinical requirements.
The document does not provide the detailed information requested in your prompt regarding acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement. It is a high-level summary.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).