Cleared Traditional

K800603 - IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD. (FDA 510(k) Clearance)

K800603 · Telectronics, Inc. · Cardiovascular device
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Mar 1980
Decision
8d
Days
-
Risk

K800603 is an FDA 510(k) clearance for the IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD..

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 8 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Telectronics, Inc. devices

Submission Details

510(k) Number K800603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date March 25, 1980
Days to Decision 8 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 125d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -