Cardiovascular Devices

United States · Last verified: 2026-09-08

Number
21 CFR 870
Type
Regulation
Issuer
U.S. FDA
Status
in_force
Authority
FDA / CDRH

What this covers

心血管器械分类目录:分诊断、监护、假体(植入)、外科和治疗五类,含起搏器、支架、人工心脏瓣膜、体外循环等,共 168 个条文。

Official text: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-870

Source: U.S. Food and Drug Administration (public domain)

Facts only; not legal advice. The official current text prevails.