# K022117: Majestik (TM) Shielded Angiography Needle, Model STAN18T71W-25, Majestik (TM) Shielded Angiogtaphy Needle, SRAN18T71WR-5

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 11, 2002 after 102 days
- Product code: DRC (Trocar)
- Device class: 2
- Regulation: 21 CFR 870.1390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951254 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011085: Guidewire Introducer Safety Needle, Medamicus, Inc. (2001)
- K951254: Safetyglide Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 1.
- (no number) Majestik Angiography Needle: named in the summary without a submission number

## Indications for use
The Merit Majestik Shielded Angiography Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. The needle incorporates a safety mechanism to help minimize needlestick injuries after use.

Source page: https://510kreport.com/device/K022117
Methodology: https://510kreport.com/methodology