# K151076: MicroTaper Needle Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Summit Access, LLC
- Decided: May 22, 2015 after 30 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974640 (1998). 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)
- K123445: Nmi Coaxial Microintroducer Set, Navilyst Medical, Inc. (2013) Summary page 4.

## Indications for use
The MicroTaper™ Needle Introducer Set is used for percutaneous introduction of a guidewire into the peripheral vasculature. The MicroTaper needle incorporates a blunting mechanism to reduce the risk of accidental needle stick injury

Source page: https://510kreport.com/device/K151076
Methodology: https://510kreport.com/methodology