510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201165Unknown

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

MEDLINE INDUSTRIES, LP - Northfield, Plymouth MN / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201165 is the FDA 510(k) clearance record for In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath, cleared for Coloplast Corp. on under FDA product code LJE (Catheter, Nephrostomy). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K201165.

Clearance record

Decision date
Received
(230 days to decision)
Product code
LJE Catheter, Nephrostomy
Device class
Unclassified
Review panel
Unknown
Applicant
Coloplast Corp. 1601 W. River Rd. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJE

Trailing 12 months

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

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