Cleared Traditional

K940231 - INTRA-AORTIC BALLOON FOR OPTIONAL SHEAT...

K940231 is the FDA 510(k) clearance for INTRA-AORTIC BALLOON FOR OPTIONAL SHEAT... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K940231 · Datascope Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
238d
Days
Class 2
Risk

K940231 is an FDA 510(k) clearance for the INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION. 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 September 13, 1994 after a review of 238 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 K940231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1994
Decision Date September 13, 1994
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
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 K940231.
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
K942454 · Datascope Corp. · Feb 1995
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
K944460 · Datascope Corp. · Dec 1994
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232 · Boston Scientific Corp · Oct 1994
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
K940178 · Datascope Corp. · Aug 1994
MODIFICATIONS TO INTRA-AORTIC BALLOONS
K932268 · Kontron Instruments, Inc. · Dec 1993
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
K925248 · Kontron Instruments, Inc. · Sep 1993