510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K955525Substantially Equivalent

Flower Infusion Catheter Model F-25/50, F-60/70

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

K955525 is the FDA 510(k) clearance record for FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70, a class II device, cleared for Interventional Innovations Corp. on under FDA product code KRA (Catheter, Continuous Flush). FDA records list 2 510(k) clearances for Interventional Innovations Corp., from to . As of , FDA records show no recalls naming K955525.

Clearance record

Decision date
Received
(248 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
Interventional Innovations Corp. 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