Cleared Traditional

K831397 - FRENCH INTRA-AORTIC 9.5 BALLOON ON KON

K831397 is an FDA 510(k) clearance for FRENCH INTRA-AORTIC 9.5 BALLOON ON KON, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K831397

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.

DSP Device Classification - Class 2, Special Controls

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 145
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K831397.
PERCOR 9.5 FR IAB ON DATASCOPE CO2
K833828 · Datascope Corp. · Feb 1985
ARIES MEDICAL MODEL 700
K833632 · Aries Medical, Inc. · May 1984
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