Cleared Special

K133074 - MEGA 8FR. 50CC AND SENSATION PLUS 8FR. ...

K133074 is the FDA 510(k) clearance for MEGA 8FR. 50CC AND SENSATION PLUS 8FR. ... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Special 510(k) pathway after a 73-day FDA review.

K133074 · Datascope Corp. · Cardiovascular device
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Dec 2013
Decision
73d
Days
Class 2
Risk

K133074 is an FDA 510(k) clearance for the MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AN.... Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on December 12, 2013 after a review of 73 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. devices

Submission Details

510(k) Number K133074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date December 12, 2013
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 123
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