Cleared Traditional

K882479 - 26MM DIAMETER HANCOCK* TROCAR BLADE AND...

K882479 is the FDA 510(k) clearance for 26MM DIAMETER HANCOCK* TROCAR BLADE AND... by Medtronic Blood Systems, Inc.. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K882479 · Medtronic Blood Systems, Inc. · Cardiovascular device
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Jul 1988
Decision
32d
Days
Class 1
Risk

K882479 is an FDA 510(k) clearance for the 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Medtronic Blood Systems, Inc. (Anaheim, US). The FDA issued a Cleared decision on July 18, 1988 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Blood Systems, Inc. devices

Submission Details

510(k) Number K882479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1988
Decision Date July 18, 1988
Days to Decision 32 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 33
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