510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K801324Substantially Equivalent

Siemens-Elema Pulse Generator 668

Siemens Elema AB, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801324 is the FDA 510(k) clearance record for SIEMENS-ELEMA PULSE GENERATOR 668, a class III device, cleared for Siemens Elema AB on under FDA product code DXY (Implantable Pacemaker Pulse-Generator). FDA records list 63 510(k) clearances for Siemens Elema AB, from to . As of , FDA records show no recalls naming K801324.

Clearance record

Decision date
Received
(181 days to decision)
Product code
DXY Implantable Pacemaker Pulse-Generator
Regulation
21 CFR 870.3610
Device class
Class III
Review panel
Cardiovascular
Applicant
Siemens Elema AB 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DXY

Trailing 12 months

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

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