# K200289: Michler-Kapp Cardiovascular Vent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Kapp Surgical Instrument, Inc.
- Decided: Jan 28, 2021 after 358 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- 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 K834352 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834352: Adult Vent Catheter, Dlp, Inc. (1984) Summary page 5.

## Indications for use
The Michler-Kapp Cardiovascular Vent Catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery up to six hours or less.

Source page: https://510kreport.com/device/K200289
Methodology: https://510kreport.com/methodology