510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K901780Substantially Equivalent

Rtm 36-05, 60-05, Rtd 36-05, 60-05 Radio. Leadwire

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

K901780 is the FDA 510(k) clearance record for RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE, a class II device, cleared for Medtronic Vascular on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K901780.

Clearance record

Decision date
Received
(175 days to decision)
Product code
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation
21 CFR 870.2900
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Vascular 60 Newark St., Haverhill MA
Third party review
No

Clearances, product code DSA

Trailing 12 months
2 clearances under product code DSA in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSA, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260