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).
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).
Page Last Updated: 08/21/2015
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