Cleared Traditional

K000776 - MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP

K000776 is an FDA 510(k) clearance for MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP, manufactured by Medtronic Cardiac Surgical Products. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K000776 · Medtronic Cardiac Surgical Products · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2001
Decision
334d
Days
Class 2
Risk

K000776 is an FDA 510(k) clearance for the MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic Cardiac Surgical Products (Grand Rapids, US). The FDA issued a Cleared decision on February 7, 2001 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Medtronic Cardiac Surgical Products devices

FDA 510(k) Submission Details - K000776

510(k) Number K000776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2000
Decision Date February 07, 2001
Days to Decision 334 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
209d slower than avg
Panel avg: 125d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

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 331
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K000776.
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · Medtronic Vascular · Aug 2001
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
K010974 · Sorin Group Italia S.R.L. · Jun 2001
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
K002019 · Sorin Group Italia S.R.L. · Mar 2001
PUMP TUBING WITH X-COATING
K003371 · Terumo Corp. · Dec 2000
QUEST MPS BACK-UP SYSYEM
K002366 · Quest Medical, Inc. · Sep 2000
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
K001565 · Edwards Lifesciences, LLC · Aug 2000