510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K002534Substantially Equivalent

Eupalamus Deflectable Stylet, Model 01545

Eupalamus, LLC, Brentwood CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002534 is the FDA 510(k) clearance record for EUPALAMUS DEFLECTABLE STYLET, MODEL 01545, a class II device, cleared for Eupalamus, LLC on under FDA product code DRB (Stylet, Catheter). FDA records list one 510(k) clearance for Eupalamus, LLC. As of , FDA records show no recalls naming K002534.

Clearance record

Decision date
Received
(63 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Eupalamus, LLC 3411 Mandeville Canyon Rd., Brentwood CA
510(k) summary
Summary
Third party review
No

Clearances, product code DRB

Trailing 12 months

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

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