# K131300: The Powerwand Safety Introducer with an Extended Dwell Catheter

- Pathway: 510(k) (Special)
- Applicant: Access Scientific, LLC
- Decided: Jun 7, 2013 after 31 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K932323 (1993). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111417: The Powerwand (R) Safety Introducer with an Extended Dwell Catheter, Access Scientific, Inc. (2011) Summary page 1.
- K121748: The Powerwand Safety Introducer with and Extended Dwell, Access Scientific, Inc. (2012) Summary page 1.

## Most influential descendants
- K162322: the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model (2016), 1 descendant of its own
- 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 (2019), 0 descendants of its own

## Recalls of this device
- Aug 16, 2013 · Class II · Z-2254-2013: Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.

## Indications for use
The POWERWAND® Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5 ml/sec at up to 300 psi fluid pressure.

Source page: https://510kreport.com/device/K131300
Methodology: https://510kreport.com/methodology