Cleared Special

K172305 - CS100/CS100i Intra-Aortic Balloon Pump

K172305 is the FDA 510(k) clearance for CS100/CS100i Intra-Aortic Balloon Pump by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Special 510(k) pathway after a 73-day FDA review.

K172305 · Datascope Corp. · Cardiovascular device
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Oct 2017
Decision
73d
Days
Class 2
Risk

K172305 is an FDA 510(k) clearance for the CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Manwah, US). The FDA issued a Cleared decision on October 12, 2017 after a review of 73 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Datascope Corp. devices

Submission Details

510(k) Number K172305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2017
Decision Date October 12, 2017
Days to Decision 73 days
Submission Type Special
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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

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 K172305.
UltraFlex IAB
K190101 · Arrow International, Inc. · Jun 2019
Fiberoptix IAB
K190117 · Arrow International, Inc. · Jun 2019
CARDIOSAVE Intra-Aortic Balloon Pump
K181122 · Datascope Corp. · May 2018
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
K163542 · Datascope Corp. · Jan 2017
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
K151254 · Datascope Corp. · Jul 2015
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
K133074 · Datascope Corp. · Dec 2013