# K003925: Prowler Infusion Catheters with Pre-Shaped Tips

- Pathway: 510(k) (Special)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Jan 8, 2001 after 19 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- 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.
37 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020680: Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips (2002), 35 descendants of its own
- K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 (2004), 17 descendants of its own
- K050130: Kerberos Proximal Solutions Rispiration System (2005), 16 descendants of its own
- K021591: Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips (2002), 16 descendants of its own
- K062275: Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 (2006), 9 descendants of its own

## Recalls of this device
- Oct 19, 2001 · Not classified · Z-0018-04: These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.

Source page: https://510kreport.com/device/K003925
Methodology: https://510kreport.com/methodology