# K183066: The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

- Pathway: 510(k) (Traditional)
- Applicant: Access Scientific, LLC
- Decided: Jul 25, 2019 after 262 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K932323 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162322: the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model, Access Scientific, LLC (2016) Summary page 4.

## Indications for use
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

Source page: https://510kreport.com/device/K183066
Methodology: https://510kreport.com/methodology