# Medical Devices; Exemptions From Premarket Notification; Class II Devices; Vascular Tunnelers
> **Food and Drug Administration** · Final rule. · Published 2000-03-03 · Effective 2000-03-03 · 65 FR 11466
## Document
- **Document number:** 00-5159
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 11466
- **CFR reference:** 21 CFR 870
- **Publication date:** 2000-03-03
- **Effective date:** 2000-03-03
- **HHS docket:** Docket No. 99P-4064
## Abstract

The Food and Drug Administration (FDA) is publishing an order granting in part a petition requesting exemption from the premarket notification requirements for vascular tunnelers with certain limitations. This rule will exempt from premarket notification stainless steel vascular tunnelers of single unit construction. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/03/03/00-5159/medical-devices-exemptions-from-premarket-notification-class-ii-devices-vascular-tunnelers)
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