Cleared Traditional

LEAD CONVERSION KIT, MODEL 341 (K781111) - FDA 510(k) Clearance

K781111 · Edwards Pacemaker Systems · Cardiovascular device
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Aug 1978
Decision
59d
Days
-
Risk

K781111 is an FDA 510(k) clearance for the LEAD CONVERSION KIT, MODEL 341.

Submitted by Edwards Pacemaker Systems (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978 after a review of 59 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 Edwards Pacemaker Systems devices

Submission Details

510(k) Number K781111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 31, 1978
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -