Cleared Traditional

K821951 - DATASCOPE MODEL 83 IABP SYSTEM

K821951 is the FDA 510(k) clearance for DATASCOPE MODEL 83 IABP SYSTEM by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K821951 · Datascope Corp. · Cardiovascular device
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Dec 1982
Decision
174d
Days
Class 2
Risk

K821951 is an FDA 510(k) clearance for the DATASCOPE MODEL 83 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 December 21, 1982 after a review of 174 days - an extended review 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: 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 K821951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1982
Decision Date December 21, 1982
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
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 K821951.
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DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL
K821065 · Datascope Corp. · Aug 1982
ADAPTATION OF KANTRON 40 CC. PDLIAB
K820166 · Kontron Instruments, Inc. · Apr 1982