Cleared Traditional

K872983 - TORAY ANTHRON ANGIOGRAPHIC CATHETERS

K872983 is the FDA 510(k) clearance for TORAY ANTHRON ANGIOGRAPHIC CATHETERS by Toray Industries (America), Inc.. It is a Class 2 Cardiovascular device (product code DQR) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K872983 · Toray Industries (America), Inc. · Cardiovascular device
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Nov 1987
Decision
112d
Days
Class 2
Risk

K872983 is an FDA 510(k) clearance for the TORAY ANTHRON ANGIOGRAPHIC CATHETERS. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Toray Industries (America), Inc. (New York, US). The FDA issued a Cleared decision on November 20, 1987 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Toray Industries (America), Inc. devices

Submission Details

510(k) Number K872983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1987
Decision Date November 20, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQR Cannula, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQR Cannula, Catheter

All 14
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K872983.
MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM
K880771 · Medsurg Industries, Inc. · May 1988
7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM
K880776 · Medsurg Industries, Inc. · May 1988
BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER
K874618 · Bentley Laboratories, Inc. · Jan 1988
NEW MODEL STYLES FOR AORTIC ARCH CANNULA
K870825 · Shiley, Inc. · Mar 1987
ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.
K870826 · Shiley, Inc. · Mar 1987
ELECATH FLUID-DRAIN ASSEMBLY
K803002 · Electro-Catheter Corp. · Dec 1980