§870.5175. Septostomy catheter.
21 C.F.R. § 870.5175
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.