510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903018Substantially Equivalent

Medtronic Andover Medical Saf-D-Fib Model 1220-002

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

K903018 is the FDA 510(k) clearance record for MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002, a class II device, cleared for Medtronic Andover Medical, Inc. on under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)). FDA records list 6 510(k) clearances for Medtronic Andover Medical, Inc., from to . As of , FDA records show no recalls naming K903018.

Clearance record

Decision date
Received
(145 days to decision)
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Regulation
21 CFR 870.5300
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Andover Medical, Inc. 60 Newark St., Haverhill MA
Third party review
No

Clearances, product code LDD

Trailing 12 months

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

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