# K983135: Blower/Mister

- Pathway: 510(k) (Traditional)
- Applicant: Cardiothoracic Systems, Inc.
- Decided: Nov 13, 1998 after 66 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) ClearView Blower/Mister: named in the summary without a submission number
- (no number) FlexiView CO₂ Blower with Mist: named in the summary without a submission number

## Most influential descendants
- K091366: Insuflow Dewheart (2009), 0 descendants of its own

## Recalls of this device
- Jan 24, 2019 · Class II · Z-0983-2019: Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

## Indications for use
The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.

Source page: https://510kreport.com/device/K983135
Methodology: https://510kreport.com/methodology