Cleared Traditional

K853400 - CCS IMPLANTABLE MAESTRO SERIES 200 CARD...

K853400 is the FDA 510(k) clearance for CCS IMPLANTABLE MAESTRO SERIES 200 CARD... by Cardiac Control Systems, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K853400 · Cardiac Control Systems, Inc. · Cardiovascular device
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Feb 1986
Decision
199d
Days
Class 3
Risk

K853400 is an FDA 510(k) clearance for the CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardiac Control Systems, Inc. (Palm Coast, US). The FDA issued a Cleared decision on February 24, 1986 after a review of 199 days - an extended review 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 Control Systems, Inc. devices

Submission Details

510(k) Number K853400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1985
Decision Date February 24, 1986
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 125d · This submission: 199d
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 340
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K853400.
MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS
K855147 · Medtronic Vascular · Mar 1986
PHOENIX MODELS 250/251 PULSE GENERATORS
K855081 · Pacesetter Systems · Mar 1986
ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS
K854482 · Medtronic Vascular · Feb 1986
MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
K860202 · Cook Pacemaker Corp. · Feb 1986
MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
K860466 · Cook Pacemaker Corp. · Feb 1986
TELEMETRY WAND MODEL
K855171 · Cardiac Pacemakers, Inc. · Jan 1986