510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962833Substantially Equivalent

Harmac Temporary Pacing Catheter with Balloon

Harmac Medical Products, Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962833 is the FDA 510(k) clearance record for HARMAC TEMPORARY PACING CATHETER WITH BALLOON, a class II device, cleared for Harmac Medical Products, Inc. on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 8 510(k) clearances for Harmac Medical Products, Inc., from to . As of , FDA records show no recalls naming K962833.

Clearance record

Decision date
Received
(474 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Harmac Medical Products, Inc. 2201 Bailey Ave., Buffalo NY
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