Cleared Traditional

K940039 - PELLETHANE 75D

K940039 is the FDA 510(k) clearance for PELLETHANE 75D by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 554-day FDA review.

K940039 · Medtronic Vascular · Cardiovascular device
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Jul 1995
Decision
554d
Days
Class 3
Risk

K940039 is an FDA 510(k) clearance for the PELLETHANE 75D. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 12, 1995 after a review of 554 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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: High-complexity regulatory submission. High regulatory complexity profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K940039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 04, 1994
Decision Date July 12, 1995
Days to Decision 554 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
429d slower than avg
Panel avg: 125d · This submission: 554d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K940039.
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K952328 · Biotronik, Inc. · Sep 1995
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
K953417 · Cook Pacemaker Corp. · Sep 1995
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
K952364 · Ela Medical, Inc. · Sep 1995
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
K950751 · Medtronic Vascular · May 1995
PIKOS E 01-B
K941937 · Biotronik, Inc. · Aug 1994
MINIX/MINIX ST PULSE GENERATORS
K932884 · Medtronic Vascular · May 1994