# K082580: Spectra Guidewire Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Spectra Medical Devices, Inc.
- Decided: Dec 8, 2008 after 94 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: 1 generation back to K851140 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851140: Teleflex Medical Introducer Needle, Teleflexmedical, Inc. (1985) Summary page 1.
- (no number) Cook Percutaneous Entry Needle (Pre-amendment device): named in the summary without a submission number

## Indications for use
The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.

Source page: https://510kreport.com/device/K082580
Methodology: https://510kreport.com/methodology