510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121614Substantially Equivalent

Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter

Boston Scientific Corporation, Marlboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121614 is the FDA 510(k) clearance record for NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER, cleared for Boston Scientific Corp on under FDA product code LJE (Catheter, Nephrostomy). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show 3 recalls naming K121614.

Clearance record

Decision date
Received
(109 days to decision)
Product code
LJE Catheter, Nephrostomy
Device class
Unclassified
Review panel
Unknown
Applicant
Boston Scientific Corp 100 Boston Scientific Way, Marlboro MA
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