Cleared Traditional

K802924 - KONTRON PERCUTAEOUS DOUBLE-LUMEN

K802924 is the FDA 510(k) clearance for KONTRON PERCUTAEOUS DOUBLE-LUMEN by Avco Medical Products. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K802924 · Avco Medical Products · Cardiovascular device
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Mar 1981
Decision
113d
Days
Class 2
Risk

K802924 is an FDA 510(k) clearance for the KONTRON PERCUTAEOUS DOUBLE-LUMEN. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Avco Medical Products (Mchenry, US). The FDA issued a Cleared decision on March 11, 1981 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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 Avco Medical Products devices

Submission Details

510(k) Number K802924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1980
Decision Date March 11, 1981
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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 - DSP System, Balloon, Intra-aortic And Control

All 124
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K802924.
DATASCOPE MODIFIED #82 IABP SYSTEM
K813182 · Datascope Corp. · Mar 1982
MODEL 84 TRANSPORT SYSTEM
K811372 · Datascope Corp. · Aug 1981
DATASCOPE PERCOR=DL DUAL-LUMEN INTRA
K810297 · Datascope Corp. · May 1981
DATASCOPE/AVCO CONNECTOR
K801601 · Datascope Corp. · Jan 1981
PERCOR DATASCOPE INTRA-AORTIC BALLOON
K802167 · Datascope Corp. · Jan 1981
INTRA-AORTIC BALLOON, TYPE S
K790775 · Datascope Corp. · Oct 1979