510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971897Substantially Equivalent

Continuous Arteriovenous Hemofiltration Catheter 10 Fr (Cavh)

Medron, LLC, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971897 is the FDA 510(k) clearance record for CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH), a class II device, cleared for Medron, Inc. on under FDA product code LFK (Catheter, Femoral). FDA records list 3 510(k) clearances for Medron, Inc., from to . As of , FDA records show no recalls naming K971897.

Clearance record

Decision date
Received
(152 days to decision)
Product code
LFK Catheter, Femoral
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medron, Inc. 3614 W. 2100 S., Salt Lake City UT
510(k) summary
Summary
Third party review
No

Clearances, product code LFK

Trailing 12 months

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

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