Cleared Abbreviated

CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX (K031636) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K031636 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
76d
Days
Class 2
Risk

K031636 is an FDA 510(k) clearance for the CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Mahwh, US). The FDA issued a Cleared decision on August 11, 2003 after a review of 76 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Datascope Corp. devices

Submission Details

510(k) Number K031636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date August 11, 2003
Days to Decision 76 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Standards-based clearance path.

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 161
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K031636.
AC3™ Range™ Intra-Aortic Balloon Pump
K250542 · Arrow International, LLC · Mar 2025
AC3™ Series IABP
K232343 · Arrow International, LLC · Aug 2023
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
K201112 · Arrow International, Inc. · May 2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
K200634 · Arrow International, Inc. · Apr 2020
AC3 Series Intra-Aortic Balloon Pump (IABP)
K192238 · Arrow International, Teleflex · Nov 2019
UltraFlex IAB
K190101 · Arrow International, Inc. · Jun 2019