# K210838: Prowler Select Plus; Prowler EX

- Pathway: 510(k) (Special)
- Applicant: Medos International SARL
- Decided: Aug 25, 2021 after 156 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945904 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021591: Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips, Cordis Neurovascular, Inc. (2002) Summary page 4.

## Indications for use
The PROWLER SELECT PLUS Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature. The PROWLER EX Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.

Source page: https://510kreport.com/device/K210838
Methodology: https://510kreport.com/methodology