510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K213442Substantially Equivalent

Extroducer Infusion Catheter System

SmartWise Sweden AB, Tullinge, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213442 is the FDA 510(k) clearance record for Extroducer Infusion Catheter System, a class II device, cleared for SmartWise Sweden AB on under FDA product code KRA (Catheter, Continuous Flush). FDA records list one 510(k) clearance for SmartWise Sweden AB. As of , FDA records show no recalls naming K213442.

Clearance record

Decision date
Received
(228 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
SmartWise Sweden AB Alfred Nobels Allé 150, Tullinge, SE
510(k) summary
Summary PDF
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