Cleared Special

DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF (K120987) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K120987 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
65d
Days
Class 2
Risk

K120987 is an FDA 510(k) clearance for the DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 6, 2012 after a review of 65 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 Medtronic, Inc. devices

Submission Details

510(k) Number K120987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2012
Decision Date June 06, 2012
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 400
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K120987.
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
K260195 · Medtronic, Inc. · Apr 2026
Venous Return Cannulae
K250937 · LivaNova USA, Inc. · Mar 2026
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
K260043 · Smart Reactors · Feb 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · Medtronic, Inc. · Feb 2026
Dual Stage Venous Cannulae
K253671 · Sorin Group Italia S.R.L. · Jan 2026
Clearview Intracoronary Shunts
K253998 · Medtronic, Inc. · Jan 2026