510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012143Substantially Equivalent

24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524

Medtronic Cardiac Surgical Products, Grand Rapids MI / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K012143 is the FDA 510(k) clearance record for 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524, a class II device, cleared for Medtronic Cardiac Surgical Products on under FDA product code DRA (Catheter, Steerable). FDA records list 7 510(k) clearances for Medtronic Cardiac Surgical Products, from to . As of , FDA records show no recalls naming K012143.

Clearance record

Decision date
Received
(106 days to decision)
Product code
DRA Catheter, Steerable
Regulation
21 CFR 870.1280
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Cardiac Surgical Products 620 Watson SW, Grand Rapids MI
510(k) summary
Summary
Third party review
No

Clearances, product code DRA

Trailing 12 months
1 clearance under product code DRA in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260