# K964571: Vision Cardioplegia Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Lifestream Int'L, Inc.
- Decided: Aug 8, 1997 after 267 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904171 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925369: BCD Advanced Blood Carioplegia Systems, Sorin Biomedica, Fiat, USA, Inc. (1993) Summary page 1.
- K904171: Scimed Cardiotherm Cardioplegia Delivery System, Scimed (1990) Summary page 1.
- (no number) Sorin Biomedical Buckberg BCD Vanguard: named in the summary without a submission number

## Indications for use
The SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System is intended to mix, cool, warm, and deliver oxygenated blood cardioplegia solution during cardiopulmonary bypass.

Source page: https://510kreport.com/device/K964571
Methodology: https://510kreport.com/methodology