PART 870 -- CARDIOVASCULAR DEVICES
Subpart F--Cardiovascular Therapeutic Devices
(a) Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.
(b) Classification. Class II (performance standards).
The information on this page is current as of April 1 2015.
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
Page Last Updated: 08/21/2015
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