Cleared Traditional

K953866 - MINIX 834M & MINIX ST 8331M PULSE GENER...

K953866 is the FDA 510(k) clearance for MINIX 834M & MINIX ST 8331M PULSE GENER... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K953866 · Medtronic Vascular · Cardiovascular device
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Dec 1995
Decision
127d
Days
Class 3
Risk

K953866 is an FDA 510(k) clearance for the MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION). 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 December 15, 1995 after a review of 127 days - within the typical 510(k) review window.

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 K953866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received August 10, 1995
Decision Date December 15, 1995
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 K953866.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
K993434 · Biotronik, Inc. · Nov 1999
OPUS S MODEL 4121 AND 4124 PACEMAKERS
K970072 · Ela Medical, Inc. · Aug 1997
PIKOS LP 01, PIKOS LP E01
K945627 · Biotronik, Inc. · Mar 1996
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
K954092 · Medtronic Vascular · Dec 1995
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