510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811399Substantially Equivalent

Edslab Closed Injectate Delivery System

American Edwards Laboratories, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811399 is the FDA 510(k) clearance record for EDSLAB CLOSED INJECTATE DELIVERY SYSTEM, a class II device, cleared for American Edwards Laboratories on under FDA product code KRB (Probe, Thermodilution). FDA records list 89 510(k) clearances for American Edwards Laboratories, from to . As of , FDA records show no recalls naming K811399.

Clearance record

Decision date
Received
(21 days to decision)
Product code
KRB Probe, Thermodilution
Regulation
21 CFR 870.1915
Device class
Class II
Review panel
Cardiovascular
Applicant
American Edwards Laboratories 4221 Richmond Rd., NW, Walker MI
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