Cleared Traditional

K880898 - MULTICOR AND PACEMAKERS

K880898 is an FDA 510(k) clearance for MULTICOR AND PACEMAKERS, manufactured by Tpl-Cordis, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K880898 · Tpl-Cordis, Inc. · Cardiovascular device
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May 1988
Decision
70d
Days
Class 3
Risk

K880898 is an FDA 510(k) clearance for the MULTICOR AND PACEMAKERS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Tpl-Cordis, Inc. (Suffield, US). The FDA issued a Cleared decision on May 6, 1988 after a review of 70 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 Tpl-Cordis, Inc. devices

FDA 510(k) Submission Details - K880898

510(k) Number K880898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date May 06, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
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 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K880898.
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) MODELS 115, 118, 215 AND 218 PACEMAKERS
K880326 · Cardiac Control Systems, Inc. · Apr 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