Cleared Traditional

K811372 - MODEL 84 TRANSPORT SYSTEM

K811372 is the FDA 510(k) clearance for MODEL 84 TRANSPORT SYSTEM by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K811372 · Datascope Corp. · Cardiovascular device
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Aug 1981
Decision
80d
Days
Class 2
Risk

K811372 is an FDA 510(k) clearance for the MODEL 84 TRANSPORT SYSTEM. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1981 after a review of 80 days - a notably fast clearance cycle.

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: 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 Datascope Corp. devices

Submission Details

510(k) Number K811372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1981
Decision Date August 03, 1981
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K811372.
DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL
K821065 · Datascope Corp. · Aug 1982
ADAPTATION OF KANTRON 40 CC. PDLIAB
K820166 · Kontron Instruments, Inc. · Apr 1982
DATASCOPE MODIFIED #82 IABP SYSTEM
K813182 · Datascope Corp. · Mar 1982
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