Cleared Traditional

K895495 - ADD'L LABELING TO MINIX MODELS AND MINI...

K895495 is the FDA 510(k) clearance for ADD'L LABELING TO MINIX MODELS AND MINI... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K895495 · Medtronic Vascular · Cardiovascular device
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Sep 1989
Decision
29d
Days
Class 3
Risk

K895495 is an FDA 510(k) clearance for the ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS. 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 September 26, 1989 after a review of 29 days - a notably fast clearance cycle.

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. 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 Vascular devices

Submission Details

510(k) Number K895495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1989
Decision Date September 26, 1989
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 338
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K895495.
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
K900461 · Ela Medical, Inc. · Mar 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
K896809 · Medtronic Vascular · Jan 1990
OPUS MODEL 4001
K894065 · Ela Medical, Inc. · Sep 1989
OPUS MODELS 4033 AND 4034
K894267 · Ela Medical, Inc. · Sep 1989
OPTIMA MPT AND SPT PACEMAKERS
K891231 · Telectronics, Inc. · Sep 1989
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
K894055 · Medtronic Vascular · Aug 1989