Cleared Traditional

K843001 - COOK PACEMAKER CORP. 116 BIOPOLAR CARDI

K843001 · Cook Pacemaker Corp. · Cardiovascular device
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Jul 1984
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K843001 is an FDA 510(k) clearance for the COOK PACEMAKER CORP. 116 BIOPOLAR CARDI.

Submitted by Cook Pacemaker Corp. (Walker, US). The FDA issued a Cleared decision on July 30, 1984.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. 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 - K843001

510(k) Number K843001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received July 30, 1984
Decision Date July 30, 1984
Days to Decision -
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -