21 CFR § 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

---
identifier: "/us/cfr/t21/s870.2855"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 870.2855 - Implantable Intra-aneurysm Pressure Measurement System."
title_number: 21
title_name: "Food and Drugs"
section_number: "870.2855"
section_name: "Implantable Intra-aneurysm Pressure Measurement System."
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"
---


# 870.2855 Implantable Intra-aneurysm Pressure Measurement System.

(a) *Identification.* Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.

(b) *Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See § 870.1 (e) for the availability of this guidance document.

[71 FR 7871, Feb. 15, 2006]