Cleared Traditional

K802224 - QUINTREX 0516 PROG. PULSE GENERATOR SYS

K802224 · Medcor, Inc. · Cardiovascular device
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Sep 1980
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K802224 is an FDA 510(k) clearance for the QUINTREX 0516 PROG. PULSE GENERATOR SYS.

Submitted by Medcor, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1980.

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 Medcor, Inc. devices

FDA 510(k) Submission Details - K802224

510(k) Number K802224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received September 12, 1980
Decision Date September 12, 1980
Days to Decision -
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -