Cleared Traditional

K831397 - FRENCH INTRA-AORTIC 9.5 BALLOON ON KON

K831397 is the FDA 510(k) clearance for FRENCH INTRA-AORTIC 9.5 BALLOON ON KON by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K831397 · Datascope Corp. · Cardiovascular device
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Nov 1983
Decision
187d
Days
Class 2
Risk

K831397 is an FDA 510(k) clearance for the FRENCH INTRA-AORTIC 9.5 BALLOON ON KON. 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 November 2, 1983 after a review of 187 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 K831397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1983
Decision Date November 02, 1983
Days to Decision 187 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
62d slower than avg
Panel avg: 125d · This submission: 187d
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 K831397.
IABP #90 SYSTEM
K831235 · Datascope Corp. · Feb 1985
PERCOR 9.5 FR IAB ON DATASCOPE CO2
K833828 · Datascope Corp. · Feb 1985
PECOR 8.5 FRENCH IAB ON A DATASCOPE
K831307 · Datascope Corp. · Nov 1983
EK COMBI MSG-1
K830410 · Jedmed Instrument Co. · Apr 1983
MINISCOPE MS-2
K830411 · Jedmed Instrument Co. · Apr 1983
PERCOR INTRA-AORTIC BALLOON INSERTION
K823342 · Datascope Corp. · Jan 1983