← Product Code [DTM](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM) · K853987

# PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE (K853987)

_Pall Biomedical Products Co. · DTM · Dec 11, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K853987

## Device Facts

- **Applicant:** Pall Biomedical Products Co.
- **Product Code:** [DTM](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM.md)
- **Decision Date:** Dec 11, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4260
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K853987](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K853987)

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