Cleared Traditional

K942454 - DATASCOPE 95 AND 97 IAB PUMP CONSOLE

K942454 is an FDA 510(k) clearance for DATASCOPE 95 AND 97 IAB PUMP CONSOLE, 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 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

FDA 510(k) Submission Details - K942454

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.

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 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
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
K935184 · St. Jude Medical, Inc. · 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