Cleared Special

K082425 - TANDEMHEART TRANSSEPTAL CANNULA- EF 72

K082425 is the FDA 510(k) clearance for TANDEMHEART TRANSSEPTAL CANNULA- EF 72 by Cardiacassist, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Special 510(k) pathway after a 27-day FDA review.

K082425 · Cardiacassist, Inc. · Cardiovascular device
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Sep 2008
Decision
27d
Days
Class 2
Risk

K082425 is an FDA 510(k) clearance for the TANDEMHEART TRANSSEPTAL CANNULA- EF 72. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on September 18, 2008 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Cardiacassist, Inc. devices

Submission Details

510(k) Number K082425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2008
Decision Date September 18, 2008
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 230
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K082425.
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