# Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter
> **Food and Drug Administration** · Final order. · Published 2017-07-27 · Effective 2017-07-27 · 82 FR 34850
## Document
- **Document number:** 2017-15786
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 34850
- **CFR reference:** 21 CFR 870
- **Publication date:** 2017-07-27
- **Effective date:** 2017-07-27
- **HHS docket:** Docket No. FDA-2017-N-1916
## Abstract

The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2017/07/27/2017-15786/medical-devices-cardiovascular-devices-classification-of-the-balloon-aortic-valvuloplasty-catheter)
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