510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K901555Substantially Equivalent

Model 1730 Neotrode with Attached Leadwire

Medtronic, Inc., Haverhill MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901555 is the FDA 510(k) clearance record for MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE, a class II device, cleared for Medtronic Vascular on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show one recall naming K901555.

Clearance record

Decision date
Received
(106 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Vascular 60 Newark St., Haverhill MA
Third party review
No

Clearances, product code DRX

Trailing 12 months

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

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