Cleared Traditional

K872983 - TORAY ANTHRON ANGIOGRAPHIC CATHETERS

K872983 is an FDA 510(k) clearance for TORAY ANTHRON ANGIOGRAPHIC CATHETERS, manufactured by Toray Industries (America), Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K872983

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
Combination Product No
PCCP Authorized No
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.

DQR Device Classification - Class 2, Special Controls

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 18
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
SUBCLAVIAN JUGULAR CATHETER SET
K820102 · Luther Medical Products, Inc. · Jan 1982