# K974642: Combicath Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Plastimed Laboratoire Pharmaceutique
- Decided: Mar 13, 1998 after 88 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923487 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923487: Bal Cath, Ballard Medical Products (1993) Summary page 1.

## Most influential descendants
- K091250: Diagnostic Catheter System (2009), 0 descendants of its own
- K024165: Dual-Lumen Catheter (2003), 0 descendants of its own

## Recalls of this device
- May 27, 2020 · Class II · Z-2487-2020: Lack of assurance of sterility
- May 27, 2020 · Class II · Z-2490-2020: Lack of assurance of sterility
- May 27, 2020 · Class II · Z-2491-2020: Lack of assurance of sterility
- May 27, 2020 · Class II · Z-2489-2020: Lack of assurance of sterility
- May 27, 2020 · Class II · Z-2492-2020: Lack of assurance of sterility
- May 27, 2020 · Class II · Z-2488-2020: Lack of assurance of sterility

## Indications for use
The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalveolar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis. The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis.

Source page: https://510kreport.com/device/K974642
Methodology: https://510kreport.com/methodology