Cleared Special

K153598 - Medtronic Bio-Medicus Adult Cannula Kit

K153598 is the FDA 510(k) clearance for Medtronic Bio-Medicus Adult Cannula Kit by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Special 510(k) pathway after a 30-day FDA review.

K153598 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
30d
Days
Class 2
Risk

K153598 is an FDA 510(k) clearance for the Medtronic Bio-Medicus Adult Cannula Kit. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on January 15, 2016 after a review of 30 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 K153598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2015
Decision Date January 15, 2016
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 148
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K153598.
Bio-Medicus Adult Cannulae Kit
K180456 · Medtronic, Inc. · Mar 2018
Tubing Pack
K171979 · Medtronic, Inc. · Oct 2017
Tubing Pack
K171308 · Medtronic, Inc. · Jun 2017
Uncoated Tubing and Connector Components
K151523 · Medtronic, Inc. · Jul 2015
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
K150567 · Medtronic, Inc. · Apr 2015
Bio-Medicus Pediatric Cannula and Introducers
K143083 · Medtronic, Inc. · Mar 2015