Cleared Traditional

K841983 - COOK PACEMAKER 216 BIPOLAR CARDIAC -

K841983 is an FDA 510(k) clearance for COOK PACEMAKER 216 BIPOLAR CARDIAC -, manufactured by Cook Pacemaker Corp.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K841983 · Cook Pacemaker Corp. · Cardiovascular device
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Jul 1984
Decision
57d
Days
Class 3
Risk

K841983 is an FDA 510(k) clearance for the COOK PACEMAKER 216 BIPOLAR CARDIAC -. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Mchenry, US). The FDA issued a Cleared decision on July 11, 1984 after a review of 57 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 Cook Pacemaker Corp. devices

FDA 510(k) Submission Details - K841983

510(k) Number K841983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1984
Decision Date July 11, 1984
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K841983.
NEOS LP
K841633 · Biotronik Sales, Inc. · Aug 1984
LEPTOS
K841635 · Biotronik Sales, Inc. · Aug 1984
COOK PACEMAKER 215 UNIPOLAR CARDIAC-
K841928 · Cook Pacemaker Corp. · Jul 1984
PULSE GENERATOR 678L
K841233 · Siemens Elema AB · Jul 1984
COOK PACEMAKER CORP. 115 UNIPOLAR CARDI
K842081 · Cook Pacemaker Corp. · Jul 1984
PULSE GENERATOR 728, 728B & 728L
K841226 · Siemens Elema AB · Jun 1984