Cleared Traditional

K821816 - ANGIOGRAPHIC CATHETER

K821816 is the FDA 510(k) clearance for ANGIOGRAPHIC CATHETER by Medi-Tech, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K821816 · Medi-Tech, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1982
Decision
64d
Days
Class 2
Risk

K821816 is an FDA 510(k) clearance for the ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1982 after a review of 64 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 Medi-Tech, Inc. devices

Submission Details

510(k) Number K821816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1982
Decision Date August 24, 1982
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
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 237
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K821816.
SIDEARM Y-ADAPTOR
K823243 · American Edwards Laboratories · Jan 1983
BRACHIAL CORONARY GUIDING CATHETER
K822862 · Advanced Cardiovascular Systems, Inc. · Oct 1982
CORONARY INFUSION KIT
K822640 · Mallinckrodt Critical Care · Sep 1982
ANGIOGRAPHY KIT
K821976 · Mallinckrodt Critical Care · Jul 1982
CORONARY INFUSION KIT
K820001 · Mallinckrodt Critical Care · Jan 1982
GANZ CORONARY REPERFUSION CATHETER
K803270 · American Edwards Laboratories · Mar 1981