Cleared Traditional

K070225 - SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE

K070225 is an FDA 510(k) clearance for SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE, manufactured by Abiomed, Inc.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K070225 · Abiomed, Inc. · Cardiovascular device
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Dec 2007
Decision
323d
Days
Class 2
Risk

K070225 is an FDA 510(k) clearance for the SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on December 13, 2007 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abiomed, Inc. devices

FDA 510(k) Submission Details - K070225

510(k) Number K070225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2007
Decision Date December 13, 2007
Days to Decision 323 days
Submission Type Traditional
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
198d slower than avg
Panel avg: 125d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 147
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K070225.
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
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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
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
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K060309 · Arrow Intl., Inc. · Apr 2006