510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K955534Substantially Equivalent

Seque Infusion Catheter (S-25,30,35,40,45,50,60)

International Innovations, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955534 is the FDA 510(k) clearance record for SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60), a class II device, cleared for International Innovations, Inc. on under FDA product code KRA (Catheter, Continuous Flush). FDA records list one 510(k) clearance for International Innovations, Inc. As of , FDA records show no recalls naming K955534.

Clearance record

Decision date
Received
(241 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
International Innovations, Inc. 2670 Patton Rd., St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code KRA

Trailing 12 months
5 clearances under product code KRA in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20262
October 20260