510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070048Substantially Equivalent

Guardian Catheter-Infant Urinary Collection Kit

Marian Medical, Inc., Louisville KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K070048 is the FDA 510(k) clearance record for GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT, a class II device, cleared for Marian Medical, Inc. on under FDA product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)). FDA records list 4 510(k) clearances for Marian Medical, Inc., from to . As of , FDA records show no recalls naming K070048.

Clearance record

Decision date
Received
(71 days to decision)
Product code
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Marian Medical, Inc. 319 Westport Dr., Louisville KY
510(k) summary
Statement
Third party review
No

Clearances, product code FCM

Trailing 12 months
1 clearance under product code FCM in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FCM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260