Cleared Traditional

K924382 - BARD INTRA AORTIC BALLOON

K924382 is the FDA 510(k) clearance for BARD INTRA AORTIC BALLOON by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K924382 · C.R. Bard, Inc. · Cardiovascular device
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Apr 1993
Decision
219d
Days
Class 2
Risk

K924382 is an FDA 510(k) clearance for the BARD(R) INTRA AORTIC BALLOON. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on April 7, 1993 after a review of 219 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K924382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date April 07, 1993
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
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 K924382.
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
K920427 · Datascope Corp. · Aug 1993
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
K905663 · Datascope Corp. · Aug 1993
SYSTEM 97
K922235 · Datascope Corp. · Apr 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
K921638 · Datascope Corp. · Feb 1993
DATASCOPE SYSTEM 95
K912629 · Datascope Corp. · Mar 1992
SYSTEM 90 AND SYSTEM 90T
K913847 · Datascope Corp. · Mar 1992