Avecor Cardiovascular, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 9
What Avecor Cardiovascular, Inc. makes
Avecor Cardiovascular, Inc. manufactures extracorporeal circulation devices for cardiac and vascular procedures, including hollow fiber oxygenators with biopassive surfaces, blood pump systems, arterial and venous blood filters, cardioplegia delivery systems, and custom tubing packs. Their portfolio also includes pre-bypass filters and venous reservoir bags designed for use during open-heart surgeries and related interventions.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. Their products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device authorization requirements. The manufacturer is based in the United States.
Catalogue
- 510(k) 510(k)
Affinity Blood Pump System Ref K964017
510(k) 510(k)Affinity Arterial Blood Filter Ref K952532
510(k) 510(k)Avecor Pre-Bypass Filter Ref K940126
510(k) 510(k)Affinity Venous Reservior Bag Ref K935717
510(k) 510(k)Affinity Cvr Ref K936003
510(k) 510(k)Myotherm (Tm) Xp Cardioplegia Delivery System Ref K971105
510(k) 510(k)Affinity Hollow Fiber Oxygenator Ref K932252
510(k) 510(k)Signature(Tm) Custom Tubing Pack Ref K924529
510(k) 510(k)
Frequently asked questions
How many devices does Avecor Cardiovascular, Inc. have in the registry?
The registry currently lists 9 devices for Avecor Cardiovascular, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Avecor Cardiovascular, Inc.'s devices?
Among its 9 most recently registered devices, Avecor Cardiovascular, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Avecor Cardiovascular, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Avecor Cardiovascular, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Avecor Cardiovascular, Inc. in the registry?
The most recently registered devices listed for Avecor Cardiovascular, Inc. include AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE, AFFINITY BLOOD PUMP SYSTEM, AFFINITY ARTERIAL BLOOD FILTER and AVECOR PRE-BYPASS FILTER.