# K961836: Maxima Forte Hardshell Venous Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Nov 1, 1996 after 172 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
Longest line of descent: 1 generation back to K891230 (1989). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933496: Maxima Filtered Hardshell Reservior, Medtronic Vascular (1993) Summary page 1.
- K891230: Maxima* Hollow Fiber Oxygenator W/Filtered Reserv., Medtronic Blood Systems, Inc. (1989) Summary page 1.
- K932254: Maxima Filtered Hardshell Reservoir, Medtronic Vascular (1993) Summary page 1.
- K922799: Capiox SX Hollow Fiber Oxygenator, Terumo Medical Corp. (1993) Summary page 1.
- K936003: Affinity CVR, Avecor Cardiovascular, Inc. (1994) Summary page 1.

## Most influential descendants
- K980935: Capiox SX Hardshell Reservoir (1998), 0 descendants of its own

## Indications for use
The MAXIMA FORTE™ Hardshell Venous Reservoir is intended for use in procedures requiring the storage and filtration of blood in the extracorporeal circuit during cardiopulmonary bypass. The MAXIMA FORTE™ Hardshell Venous Reservoir is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically rcturn the blood to the patient for volume replacement.

Source page: https://510kreport.com/device/K961836
Methodology: https://510kreport.com/methodology