Cleared Traditional

SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC

K852331 · Scholten Surgical Instruments, Inc. · Radiology
Aug 1986
Decision
427d
Days
Class 2
Risk

About This 510(k) Submission

K852331 is an FDA 510(k) clearance for the SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Scholten Surgical Instruments, Inc. (Redwood City, US). The FDA issued a Cleared decision on August 1, 1986, 427 days after receiving the submission on May 31, 1985. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K852331 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1985
Decision Date August 01, 1986
Days to Decision 427 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IZI — System, X-ray, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1600

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