Cleared Traditional

K893243 - INTRA AORTIC BALLOON

K893243 is the FDA 510(k) clearance for INTRA AORTIC BALLOON by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K893243 · Datascope Corp. · Cardiovascular device
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Jun 1989
Decision
19d
Days
Class 2
Risk

K893243 is an FDA 510(k) clearance for the INTRA AORTIC BALLOON. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on June 20, 1989 after a review of 19 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 K893243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1989
Decision Date June 20, 1989
Days to Decision 19 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
106d faster than avg
Panel avg: 125d · This submission: 19d
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 K893243.
9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892798 · Kontron Instruments, Inc. · Sep 1989
8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892799 · Kontron Instruments, Inc. · Sep 1989
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000
K892878 · Kontron Instruments, Inc. · Sep 1989
10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC
K882274 · Kontron Instruments, Inc. · Mar 1989
9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON
K882508 · Kontron Instruments, Inc. · Mar 1989
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL
K880289 · Datascope Corp. · Jun 1988