# K992657: Ibc VRV, Model 1350

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corp.
- Decided: Feb 18, 2000 after 193 days
- Product code: DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4430
- 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) Omni Model RLV-2100"B” VRV valve: named in the summary without a submission number

## Indications for use
The IBC VRV is indicated for use as an intracardiac suction control valve for left ventricular venting during cardiopulmonary bypass surgery (up to six hours).

Source page: https://510kreport.com/device/K992657
Methodology: https://510kreport.com/methodology