← Product Code [KRJ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ) · K812539

# PRE-BYPASS FILTER (K812539)

_Gelman Sciences, Inc. · KRJ · Oct 13, 1981 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K812539

## Device Facts

- **Applicant:** Gelman Sciences, Inc.
- **Product Code:** [KRJ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ.md)
- **Decision Date:** Oct 13, 1981
- **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/K812539](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/KRJ/K812539)

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