510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964469Substantially Equivalent

700-F Series Stimulation Electrodes

Cardiotronics Systems, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964469 is the FDA 510(k) clearance record for 700-F SERIES STIMULATION ELECTRODES, a class II device, cleared for Cardiotronics Systems, Inc. on under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)). FDA records list 4 510(k) clearances for Cardiotronics Systems, Inc., from to . As of , FDA records show 4 recalls naming K964469.

Clearance record

Decision date
Received
(34 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
Cardiotronics Systems, Inc. 5966 La Pl. Ct., Carlsbad CA
510(k) summary
Statement
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