Cleared Special

K112372 - CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

K112372 is an FDA 510(k) clearance for CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP, manufactured by Cardiac Assist, Maquet Cardiovascular, LLC. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Special 510(k) pathway after a 29-day FDA review.

K112372 · Cardiac Assist, Maquet Cardiovascular, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
29d
Days
Class 2
Risk

K112372 is an FDA 510(k) clearance for the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Cardiac Assist, Maquet Cardiovascular, LLC (Manwah, US). The FDA issued a Cleared decision on September 15, 2011 after a review of 29 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.

FDA 510(k) Submission Details - K112372

510(k) Number K112372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2011
Decision Date September 15, 2011
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 156
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K112372.
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
K133074 · Datascope Corp. · Dec 2013
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K122628 · Datascope Corp., Cardiac Assist Division · Sep 2012
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
K120868 · Datascope Corp., Cardiac Assist Division · Apr 2012
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
K112327 · Cardiac Assist, Maquet Cardiovascular, LLC · Sep 2011
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
K091449 · Datascope Corp., Cardiac Assist Division · Jun 2009
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
K082746 · Insightra Medical, Inc. · Jan 2009
K112372 · CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
Download PDF FDA Summary Cardiac Assist, Maque…