Cleared Special

K122628 - SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES

K122628 is an FDA 510(k) clearance for SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC..., 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 9-day FDA review.

K122628 · Datascope Corp., Cardiac Assist Division · Cardiovascular device
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Sep 2012
Decision
9d
Days
Class 2
Risk

K122628 is an FDA 510(k) clearance for the SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES. 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 September 6, 2012 after a review of 9 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 - K122628

510(k) Number K122628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2012
Decision Date September 06, 2012
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
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 145
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K122628.
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K120868 · Datascope Corp., Cardiac Assist Division · Apr 2012
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
K112372 · Cardiac Assist, Maquet Cardiovascular, LLC · Sep 2011
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
K112327 · Cardiac Assist, Maquet Cardiovascular, LLC · Sep 2011