Cleared Traditional

RNS STERILE, DISPOSABLE CT BIOPSY TRAY

K955685 · Contour Fabricators of Florida, Inc. · Cardiovascular
Oct 1996
Decision
295d
Days
Class 2
Risk

About This 510(k) Submission

K955685 is an FDA 510(k) clearance for the RNS STERILE, DISPOSABLE CT BIOPSY TRAY, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on October 4, 1996, 295 days after receiving the submission on December 14, 1995. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K955685 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1995
Decision Date October 04, 1996
Days to Decision 295 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

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