510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123605Substantially Equivalent

Smartflow Catheter

Mri Interventions, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123605 is the FDA 510(k) clearance record for SMARTFLOW CATHETER, a class II device, cleared for Mri Interventions, Inc. on under FDA product code HCA (Catheter, Ventricular). FDA records list 14 510(k) clearances for Mri Interventions, Inc., from to . As of , FDA records show no recalls naming K123605.

Clearance record

Decision date
Received
(268 days to decision)
Product code
HCA Catheter, Ventricular
Regulation
21 CFR 882.4100
Device class
Class II
Review panel
Neurology
Applicant
Mri Interventions, Inc. 5 Musick, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HCA

Trailing 12 months

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

FDA records show no clearances under product code HCA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCA, 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