Cleared Traditional

MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT (K970341) - FDA 510(k) Clearance

K970341 · Medtronic PS Medical · General Hospital
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Apr 1997
Decision
84d
Days
-
Risk

K970341 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT.

Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital 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 PS Medical devices

Submission Details

510(k) Number K970341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1997
Decision Date April 23, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIS
Device Class -