← Product Code [KRJ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ) · K832594

# PRE-BYPASS FILTER #EC-PBF SERIES (K832594)

_Gish Biomedical, Inc. · KRJ · Sep 20, 1983 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K832594

## Device Facts

- **Applicant:** Gish Biomedical, Inc.
- **Product Code:** [KRJ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ.md)
- **Decision Date:** Sep 20, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4280
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris from the circuit prior to initiating bypass. The device is not used to filter blood.

## Special Controls

*Classification.* Class II (special 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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K832594](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K832594)

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