510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923368Substantially Equivalent

Magic Infusion Catheter

Target Therapeutics, Freemont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923368 is the FDA 510(k) clearance record for MAGIC INFUSION CATHETER, a class II device, cleared for Target Therapeutics on under FDA product code KRA (Catheter, Continuous Flush). FDA records list 70 510(k) clearances for Target Therapeutics, from to . As of , FDA records show no recalls naming K923368.

Clearance record

Decision date
Received
(272 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
Target Therapeutics 47201 Lakeview Blvd., Freemont CA
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