510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960849Substantially Equivalent

Magno Alarm

Cardiac Assist Devices, Inc., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960849 is the FDA 510(k) clearance record for MAGNO ALARM, a class I device, cleared for Cardiac Assist Devices, Inc. on under FDA product code DTG (Magnet, Test, Pacemaker). FDA records list 3 510(k) clearances for Cardiac Assist Devices, Inc., from to . As of , FDA records show no recalls naming K960849.

Clearance record

Decision date
Received
(400 days to decision)
Product code
DTG Magnet, Test, Pacemaker
Regulation
21 CFR 870.3690
Device class
Class I
Review panel
Cardiovascular
Applicant
Cardiac Assist Devices, Inc. 11000 Cedar Ave., Suite 451, Cleveland OH
510(k) summary
Summary
Third party review
No

Clearances, product code DTG

Trailing 12 months

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

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