510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933450Substantially Equivalent

Closed Tip Multi-Electrode Catheter, Modification

Electro-Catheter Corp., Rahway NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933450 is the FDA 510(k) clearance record for CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION, a class II device, cleared for Electro-Catheter Corp. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 35 510(k) clearances for Electro-Catheter Corp., from to . As of , FDA records show no recalls naming K933450.

Clearance record

Decision date
Received
(646 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Electro-Catheter Corp. 2100 Felver Ct., Rahway NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DRF

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