Cleared Traditional

FILTECH TECHNETIUM-99MM RADIOPHARMACEU (K833686) - FDA 510(k) Clearance

K833686 · Summa Medical Corp. · Cardiovascular device
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Feb 1984
Decision
120d
Days
-
Risk

K833686 is an FDA 510(k) clearance for the FILTECH TECHNETIUM-99MM RADIOPHARMACEU.

Submitted by Summa Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1984 after a review of 120 days - within the typical 510(k) review window.

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 Summa Medical Corp. devices

Submission Details

510(k) Number K833686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1983
Decision Date February 28, 1984
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -