PART 870 -- CARDIOVASCULAR DEVICES
Subpart B--Cardiovascular Diagnostic Devices
(a) Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.
(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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