510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970341Substantially Equivalent

Medtronic Ps Medical Rivas Vascular Catheter Repair Kit

Medtronic PS Medical, Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970341 is the FDA 510(k) clearance record for MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT, cleared for Medtronic PS Medical on under FDA product code LIS. FDA records list 14 510(k) clearances for Medtronic PS Medical, from to . As of , FDA records show no recalls naming K970341.

Clearance record

Decision date
Received
(84 days to decision)
Product code
LIS
Review panel
Unknown
Applicant
Medtronic PS Medical 125 Cremona Dr., Goleta CA
510(k) summary
Summary
Third party review
No

Clearances, product code LIS

Trailing 12 months

FDA records hold no clearances under product code LIS in the trailing twelve months.

FDA records show no clearances under product code LIS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260