# K974745: Manan Gwi Guide Wire Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Apr 6, 1998 after 108 days
- Product code: DRC (Trocar)
- Device class: 2
- Regulation: 21 CFR 870.1390
- 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: 1 generation back to K851834 (1985). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851834: Manan Gwi Guide Wire Introducer, Manan Manufacturing Co., Inc. (1985) Summary page 1.

## Most influential descendants
- K021275: Micomed Posterior Doublerod System (2002), 0 descendants of its own

## Recalls of this device
- Sep 1, 2009 · Not classified · Z-2018-2010: Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Acces

## Indications for use
The Manan™ Guide Wire Introducer is intended for use as an anterior, single wall arterial percutaneous puncture.

Source page: https://510kreport.com/device/K974745
Methodology: https://510kreport.com/methodology