← Product Code [DXT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT) · K851402

# LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE (K851402)

_Medi-Tech, Inc. · DXT · Jun 10, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT/K851402

## Device Facts

- **Applicant:** Medi-Tech, Inc.
- **Product Code:** [DXT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT.md)
- **Decision Date:** Jun 10, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1650
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT/K851402](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXT/K851402)

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