Cleared Traditional

K880326 - MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS

K880326 is an FDA 510(k) clearance for MAESTRO MODELS 115, manufactured by Cardiac Control Systems, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K880326 · Cardiac Control Systems, Inc. · Cardiovascular device
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Apr 1988
Decision
76d
Days
Class 3
Risk

K880326 is an FDA 510(k) clearance for the MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS. 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 April 11, 1988 after a review of 76 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 Control Systems, Inc. devices

FDA 510(k) Submission Details - K880326

510(k) Number K880326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date April 11, 1988
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K880326.
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
K882474 · Ela Medical, Inc. · Sep 1988
OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
K882476 · Ela Medical, Inc. · Sep 1988
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
K881837 · Telectronics, Inc. · Jul 1988
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
K880422 · Cardiac Control Systems, Inc. · Mar 1988
CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.
K874158 · Cardiac Control Systems, Inc. · Dec 1987
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
K874394 · Intermedics, Inc. · Nov 1987