# K953821: Biocor 200 Hardshell Venous Reservior

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Mar 7, 1996 after 205 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Affinity CVR Cardiotomy/Venous Reservoir with filter (Avecor Cardiovascular): named in the summary without a submission number
- (no number) Sorin HSVRF Hardshell Venous Reservoir with Integral Cardiotomy Filter (Sorin Biomedical): named in the summary without a submission number

## Indications for use
The Biocor™ 200 Hardshell Venous Reservoir is safe and effective as a storage reservoir for venous blood and for blood recovered by intrathoracic suction.

Source page: https://510kreport.com/device/K953821
Methodology: https://510kreport.com/methodology