Cleared Traditional

K802353 - MICRO THIN-PII

K802353 is the FDA 510(k) clearance for MICRO THIN-PII by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

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
Combination Product No
PCCP Authorized No
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 279
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K802353.
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274
K803197 · Telectronics, Inc. · Jan 1981
CYBERLITH PROGRAMMER
K801338 · Intermedics, Inc. · Jan 1981
MICRO THIN-DII, #0521
K802352 · Cardiac Pacemakers, Inc. · Dec 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0623
K803034 · Cardiac Pacemakers, Inc. · Dec 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0621
K803035 · Cardiac Pacemakers, Inc. · Dec 1980
SIEMENS-ELEMA PULSE GENERATOR 668
K801324 · Siemens Elema AB · Dec 1980