Cleared Traditional

K801027 - MDS IMAGER (FDA 510(k) Clearance)

K801027 · Medtronic Vascular · Radiology device
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May 1980
Decision
27d
Days
-
Risk

K801027 is an FDA 510(k) clearance for the MDS IMAGER.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology 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 Medtronic Vascular devices

Submission Details

510(k) Number K801027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1980
Decision Date May 28, 1980
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -