Cleared Traditional

K821976 - ANGIOGRAPHY KIT

K821976 is the FDA 510(k) clearance for ANGIOGRAPHY KIT by Mallinckrodt Critical Care. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821976 · Mallinckrodt Critical Care · Cardiovascular device
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Jul 1982
Decision
14d
Days
Class 2
Risk

K821976 is an FDA 510(k) clearance for the ANGIOGRAPHY KIT. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Walker, US). The FDA issued a Cleared decision on July 20, 1982 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K821976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1982
Decision Date July 20, 1982
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 304
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K821976.
BRACHIAL CORONARY GUIDING CATHETER
K822862 · Advanced Cardiovascular Systems, Inc. · Oct 1982
CORONARY INFUSION KIT
K822640 · Mallinckrodt Critical Care · Sep 1982
ANGIOGRAPHIC CATHETER
K821816 · Medi-Tech, Inc. · Aug 1982
CORONARY INFUSION KIT
K820001 · Mallinckrodt Critical Care · Jan 1982
GANZ CORONARY REPERFUSION CATHETER
K803270 · American Edwards Laboratories · Mar 1981
BAIM TM CORONARY SINUS FLOW THERMAL
K810360 · Electro-Catheter Corp. · Mar 1981