Cleared Traditional

MICRO THIN-PII, #0523 (K802353) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K802353 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Dec 1980
Decision
88d
Days
Class 3
Risk

K802353 is an FDA 510(k) clearance for the MICRO THIN-PII, #0523. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 88 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K802353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1980
Decision Date December 22, 1980
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 460
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K802353.
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
K953866 · Medtronic Vascular · Dec 1995
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
K954092 · Medtronic Vascular · Dec 1995
PELLETHANE 75D
K940039 · Medtronic Vascular · Jul 1995
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
K950751 · Medtronic Vascular · May 1995
MINIX/MINIX ST PULSE GENERATORS
K932884 · Medtronic Vascular · May 1994
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
K930770 · Medtronic Vascular · May 1993