Cleared Special

DUAL SHOT ALPHA

K071691 · Nemoto Kyorindo Co., Ltd. · Cardiovascular
Dec 2007
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K071691 is an FDA 510(k) clearance for the DUAL SHOT ALPHA, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Nemoto Kyorindo Co., Ltd. (Laguna Hills, US). The FDA issued a Cleared decision on December 19, 2007, 182 days after receiving the submission on June 20, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K071691 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2007
Decision Date December 19, 2007
Days to Decision 182 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXT — Injector And Syringe, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

Similar Devices — DXT Injector And Syringe, Angiographic

All 205
Extension tube
K251788 · Zhuhai DR Medical Instruments Co., Ltd. · Mar 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
K252891 · Bayer Medical Care, Inc. · Feb 2026
High Pressure Tubing
K244038 · Shandong Int Medical Instruments Co., Ltd. · Sep 2025
Angiography Injector
K242143 · Shandong Int Medical Instruments Co., Ltd. · Dec 2024
Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
K242212 · Nemoto Kyorindo Co., Ltd. · Aug 2024
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109 · Shenzhen Boon Medical Supply Co., Ltd. · Aug 2024