510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851913Substantially Equivalent

Cordis High-Torque Temp. Pervenous Lead W/depth Ma

Cordis US Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851913 is the FDA 510(k) clearance record for CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA, a class II device, cleared for Cordis Corp. on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K851913.

Clearance record

Decision date
Received
(138 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis Corp. P.O. Box 025700, Miami FL
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