Cleared Traditional

K813182 - DATASCOPE MODIFIED #82 IABP SYSTEM

K813182 is the FDA 510(k) clearance for DATASCOPE MODIFIED #82 IABP SYSTEM by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K813182 · Datascope Corp. · Cardiovascular device
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Mar 1982
Decision
139d
Days
Class 2
Risk

K813182 is an FDA 510(k) clearance for the DATASCOPE MODIFIED #82 IABP SYSTEM. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Walker, US). The FDA issued a Cleared decision on March 31, 1982 after a review of 139 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 Datascope Corp. devices

Submission Details

510(k) Number K813182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1981
Decision Date March 31, 1982
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 K813182.
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
K820882 · Datascope Corp. · Oct 1982
DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL
K821065 · Datascope Corp. · Aug 1982
ADAPTATION OF KANTRON 40 CC. PDLIAB
K820166 · Kontron Instruments, Inc. · Apr 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