510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K052389Substantially Equivalent

I-Port

Patton Medical Devices, Eagle ID / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052389 is the FDA 510(k) clearance record for I-PORT, a class II device, cleared for Patton Medical Devices on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list one 510(k) clearance for Patton Medical Devices. As of , FDA records show no recalls naming K052389.

Clearance record

Decision date
Received
(9 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Patton Medical Devices P.O. Box 1490, Eagle ID
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code FOZ

Trailing 12 months
9 clearances under product code FOZ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260