Cleared Abbreviated

K031636 - CS100 INTRA-AORTIC BALLOON PUMP

K031636 is the FDA 510(k) clearance for CS100 INTRA-AORTIC BALLOON PUMP by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Abbreviated 510(k) pathway after a 76-day FDA review.

K031636 · Datascope Corp. · Cardiovascular device
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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
Combination Product No
PCCP Authorized No
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 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K031636.
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
K060309 · Arrow Intl., Inc. · Apr 2006
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
K041281 · Datascope Corp. · Jun 2004
INTRA-AORTIC BALLOON (IAB)
K040801 · Arrow Intl., Inc. · May 2004
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
K031569 · Datascope Corp. · Jun 2003
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
K021462 · Arrow Intl., Inc. · Jun 2002
DATASCOPE'S 8FR. ALT B IAB
K020257 · Datascope Corp. · Apr 2002