Cleared Traditional

CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS (K844360) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K844360 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
217d
Days
Class 3
Risk

K844360 is an FDA 510(k) clearance for the CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on June 18, 1985 after a review of 217 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 Cordis Corp. devices

Submission Details

510(k) Number K844360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date June 18, 1985
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 181
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K844360.
SUPRIMA II MODEL 253-23
K852430 · Intermedics, Inc. · Jul 1985
SUPRIMA II MODEL 254-28
K852432 · Intermedics, Inc. · Jul 1985
MULTICOR S, MODELS 330A/331A
K851420 · Cordis Corp. · Jun 1985
STANICOR GAMMA 333B/334A
K851416 · Cordis Corp. · Jun 1985
MULTICOR GAMMA MODELS 336/337
K851417 · Cordis Corp. · Jun 1985
OMNI-ATRICOR MODEL 308A
K851418 · Cordis Corp. · Jun 1985