510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K874465Substantially Equivalent

Sorenson Thermo. Flow-Direct Trans Pace Cath/lead

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

K874465 is the FDA 510(k) clearance record for SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD, a class II device, cleared for Abbott Laboratories on under FDA product code DYG (Catheter, Flow Directed). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K874465.

Clearance record

Decision date
Received
(208 days to decision)
Product code
DYG Catheter, Flow Directed
Regulation
21 CFR 870.1240
Device class
Class II
Review panel
Cardiovascular
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review
No

Clearances, product code DYG

Trailing 12 months

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

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