21 CFR § 870.4500 - Cardiovascular surgical instruments.

---
identifier: "/us/cfr/t21/s870.4500"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 870.4500 - Cardiovascular surgical instruments."
title_number: 21
title_name: "Food and Drugs"
section_number: "870.4500"
section_name: "Cardiovascular surgical instruments."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "870"
part_name: "CARDIOVASCULAR DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 7907, Feb. 5, 1980, unless otherwise noted."
cfr_part: "870"
---


# 870.4500 Cardiovascular surgical instruments.

(a) *Identification.* Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 FR 38797, July 25, 2001]