Cleared Special

K091449 - DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02

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

K091449 · Datascope Corp., Cardiac Assist Division · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K091449

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.

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 146
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K091449.
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
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K112327 · Cardiac Assist, Maquet Cardiovascular, LLC · Sep 2011
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
K070225 · Abiomed, Inc. · Dec 2007
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
K063525 · Datascope Corp. · Jan 2007
SUPRACOR BALLOON CATHETER
K062582 · Abiomed, Inc. · Dec 2006