← Product Code [DTN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN) · K844367

# CARDIOTOMY RESERVOIR W/FILTER BCR-2500 (K844367)

_American Bentley · DTN · Jan 14, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K844367

## Device Facts

- **Applicant:** American Bentley
- **Product Code:** [DTN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN.md)
- **Decision Date:** Jan 14, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4400
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

## Special Controls

*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, 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/DTN/K844367](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K844367)

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