Cleared Traditional

K870826 - ADDITIONAL LETTER DESIGNATION FOR AORTI...

K870826 is an FDA 510(k) clearance for ADDITIONAL LETTER DESIGNATION FOR AORTI..., manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DQR cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K870826 · Shiley, Inc. · Cardiovascular device
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Mar 1987
Decision
20d
Days
Class 2
Risk

K870826 is an FDA 510(k) clearance for the ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on March 23, 1987 after a review of 20 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shiley, Inc. devices

FDA 510(k) Submission Details - K870826

510(k) Number K870826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date March 23, 1987
Days to Decision 20 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
105d faster than avg
Panel avg: 125d · This submission: 20d
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 14
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K870826.
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
ELECATH FLUID-DRAIN ASSEMBLY
K803002 · Electro-Catheter Corp. · Dec 1980
CANNULA, INTRAVENOUS, R
K770512 · Sherwood Medical Industries · Mar 1977