510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884318Substantially Equivalent

Thermoset(tm) Closed Loop Delivery System

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884318 is the FDA 510(k) clearance record for THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM, a class II device, cleared for Abbott Laboratories on under FDA product code KRB (Probe, Thermodilution). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 3 recalls naming K884318.

Clearance record

Decision date
Received
(61 days to decision)
Product code
KRB Probe, Thermodilution
Regulation
21 CFR 870.1915
Device class
Class II
Review panel
Cardiovascular
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
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