21 CFR 870.1350
§ 870.1350 Catheter balloon repair kit.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.1350, § 870.1350 Catheter balloon repair kit, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89892
- Permanent ID
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Full text
(a) Identification. A catheter balloon repair kit is a device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to effect the repair or replacement.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any catheter balloon repair kit that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a catheter balloon repair kit that was in commercial distribution before May 28, 1976. Any other catheter balloon repair kit shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.