510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033858Substantially Equivalent

Temporary Bipolar Myocardial Pacing Wire

Alto Development Corp, Gemert, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K033858 is the FDA 510(k) clearance record for TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE, a class II device, cleared for European Custom Manufacturing BV on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 12 510(k) clearances for ALTO DEVELOPMENT CORP., from to . As of , FDA records show one recall naming K033858.

Clearance record

Decision date
Received
(214 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
European Custom Manufacturing BV Oost-Om 54, Gemert, NL
510(k) summary
Statement
Third party review
No

Clearances, product code LDF

Trailing 12 months
1 clearance under product code LDF in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LDF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260