Cleared Traditional

K946188 - CCDS MAESTRO II SERIES 200 CADIAC PACEM...

K946188 is the FDA 510(k) clearance for CCDS MAESTRO II SERIES 200 CADIAC PACEM... by Cardiac Control Systems, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K946188 · Cardiac Control Systems, Inc. · Cardiovascular device
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May 1995
Decision
146d
Days
Class 3
Risk

K946188 is an FDA 510(k) clearance for the CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER. 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 May 15, 1995 after a review of 146 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 Cardiac Control Systems, Inc. devices

Submission Details

510(k) Number K946188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 20, 1994
Decision Date May 15, 1995
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
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 K946188.
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
K953417 · Cook Pacemaker Corp. · Sep 1995
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
K952364 · Ela Medical, Inc. · Sep 1995
PELLETHANE 75D
K940039 · Medtronic Vascular · Jul 1995
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
K950751 · Medtronic Vascular · May 1995
PIKOS E 01-B
K941937 · Biotronik, Inc. · Aug 1994
MINIX/MINIX ST PULSE GENERATORS
K932884 · Medtronic Vascular · May 1994