# K021591: Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips

- Pathway: 510(k) (Special)
- Applicant: Cordis Neurovascular, Inc.
- Decided: May 22, 2002 after 7 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945904 (1995). 7 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965181: Ces Infusion Catheter, Cordis Neurovascular, Inc. (1997) Summary page 2.
- K972518: Transit/Rapidtransit/Speedster/Prowler Infusion Catheter, Cordis Neurovascular, Inc. (1997) Summary page 2.
- K993266: Prowler Plus Infusion Catheter, Cordis Neurovascular, Inc. (1999) Summary page 2.
- K020680: Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips, Cordis Neurovascular, Inc. (2002) Summary page 2.

## Most influential descendants
- K151638: Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter (2015), 6 descendants of its own
- K180959: Phenom 27 Catheter (2018), 4 descendants of its own
- K113289: Orion Micro Catheter (2012), 3 descendants of its own
- K210230: Phenom Catheters (2021), 2 descendants of its own
- K150894: VIA 21 Microcatheter (2015), 2 descendants of its own

## Recalls of this device
- Aug 11, 2006 · Not classified · Z-1483-06: Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER S
- Aug 11, 2006 · Not classified · Z-1482-06: Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER S

## Indications for use
The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.

Source page: https://510kreport.com/device/K021591
Methodology: https://510kreport.com/methodology