510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871915Substantially Equivalent

Miniature Temp. Cardiac Pacemakers Ec4542 & Ec4543

Pace Medical, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871915 is the FDA 510(k) clearance record for MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543, a class II device, cleared for Pace Medical on under FDA product code DTE (Pulse-Generator, Pacemaker, External). FDA records list 19 510(k) clearances for Pace Medical, from to . As of , FDA records show no recalls naming K871915.

Clearance record

Decision date
Received
(23 days to decision)
Product code
DTE Pulse-Generator, Pacemaker, External
Regulation
21 CFR 870.3600
Device class
Class II
Review panel
Cardiovascular
Applicant
Pace Medical 391 Totten Pond Rd., Waltham MA
Third party review
No

Clearances, product code DTE

Trailing 12 months

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

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