510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833519Substantially Equivalent

Pulse Generator Model 688

Burditt & Calkins-Siemens-Elema, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833519 is the FDA 510(k) clearance record for PULSE GENERATOR MODEL 688, a class III device, cleared for Burditt & Calkins-Siemens-Elema on under FDA product code DXY (Implantable Pacemaker Pulse-Generator). FDA records list 10 510(k) clearances for Burditt & Calkins-Siemens-Elema, from to . As of , FDA records show no recalls naming K833519.

Clearance record

Decision date
Received
(111 days to decision)
Product code
DXY Implantable Pacemaker Pulse-Generator
Regulation
21 CFR 870.3610
Device class
Class III
Review panel
Cardiovascular
Applicant
Burditt & Calkins-Siemens-Elema 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