Cleared Traditional

K062582 - SUPRACOR BALLOON CATHETER

K062582 is an FDA 510(k) clearance for SUPRACOR BALLOON CATHETER, 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 105-day FDA review.

K062582 · Abiomed, Inc. · Cardiovascular device
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Dec 2006
Decision
105d
Days
Class 2
Risk

K062582 is an FDA 510(k) clearance for the SUPRACOR BALLOON CATHETER. 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 14, 2006 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K062582

510(k) Number K062582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date December 14, 2006
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 125
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K062582.
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K063525 · Datascope Corp. · Jan 2007
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
K060309 · Arrow Intl., Inc. · Apr 2006
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
K041281 · Datascope Corp. · Jun 2004
INTRA-AORTIC BALLOON (IAB)
K040801 · Arrow Intl., Inc. · May 2004