510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K900317Substantially Equivalent

Pacemate Flow Directed Thermal Dilution Catheter

Elecath, Rahway NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900317 is the FDA 510(k) clearance record for PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER, a class II device, cleared for Elecath on under FDA product code KRB (Probe, Thermodilution). FDA records list one 510(k) clearance for Elecath. As of , FDA records show no recalls naming K900317.

Clearance record

Decision date
Received
(150 days to decision)
Product code
KRB Probe, Thermodilution
Regulation
21 CFR 870.1915
Device class
Class II
Review panel
Cardiovascular
Applicant
Elecath 2100 Felver Ct., Rahway NJ
Third party review
No

Clearances, product code KRB

Trailing 12 months

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

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