# K210047: Stiletto Extended Dwell Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Piper Access, LLC
- Decided: Aug 27, 2021 after 231 days
- Product code: PND (Midline Catheter)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162377: PowerGlide Pro Midline Catheter, C.R. Bard, Inc. (2016) Summary page 4.

## Indications for use
The Stiletto Extended Dwell Catheter is inserted into a patient's vascular system for short-term use (<28 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Stiletto Extended Dwell Catheter is suitable for use with power injection.

Source page: https://510kreport.com/device/K210047
Methodology: https://510kreport.com/methodology