Regulations last checked for updates: Oct 18, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
All TitlesTitle 21Chapter IPart 870Subpart F - Subpart F—Cardiovascular Therapeutic Devices
View all text of Subpart F [§ 870.5050 - § 870.5925]
§ 870.5175 - Septostomy catheter.

(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).

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.
cite as: 21 CFR 870.5175
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