Cleared Special

K112327 - SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES

K112327 is an FDA 510(k) clearance for SENSATION(TM) PLUS 8FR. 50CC INTRA-AORT..., 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 28-day FDA review.

K112327 · 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
28d
Days
Class 2
Risk

K112327 is an FDA 510(k) clearance for the SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES. 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 9, 2011 after a review of 28 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 - K112327

510(k) Number K112327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2011
Decision Date September 09, 2011
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 K112327.
SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
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
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
K112372 · 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
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
K070225 · Abiomed, Inc. · Dec 2007
K112327 · SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
Download PDF FDA Summary Cardiac Assist, Maque…