Cleared Special

K091449 - DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALL...

K091449 is the FDA 510(k) clearance for DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALL... by Datascope Corp., Cardiac Assist Division. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Special 510(k) pathway after a 31-day FDA review.

K091449 · Datascope Corp., Cardiac Assist Division · Cardiovascular device
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Jun 2009
Decision
31d
Days
Class 2
Risk

K091449 is an FDA 510(k) clearance for the DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0.... Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp., Cardiac Assist Division (Fairfield, US). The FDA issued a Cleared decision on June 18, 2009 after a review of 31 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., Cardiac Assist Division devices

Submission Details

510(k) Number K091449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2009
Decision Date June 18, 2009
Days to Decision 31 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
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 124
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K091449.
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
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MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
K133074 · Datascope Corp. · Dec 2013
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
K063525 · Datascope Corp. · Jan 2007
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
K060309 · Arrow Intl., Inc. · Apr 2006
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
K041281 · Datascope Corp. · Jun 2004