Cleared Traditional

K942454 - DATASCOPE 95 AND 97 IAB PUMP CONSOLE

K942454 is the FDA 510(k) clearance for DATASCOPE 95 AND 97 IAB PUMP CONSOLE by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K942454 · Datascope Corp. · Cardiovascular device
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Feb 1995
Decision
277d
Days
Class 2
Risk

K942454 is an FDA 510(k) clearance for the DATASCOPE 95 AND 97 IAB PUMP CONSOLE. 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 February 24, 1995 after a review of 277 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 K942454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1994
Decision Date February 24, 1995
Days to Decision 277 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 125d · This submission: 277d
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 K942454.
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON
K945230 · Arrow Intl., Inc. · May 1995
BSC/CA MODEL 940 IAB
K940298 · Boston Scientific Corp · Apr 1995
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
K943919 · Boston Scientific Corp · Mar 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
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
K940231 · Datascope Corp. · Sep 1994