510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914185Substantially Equivalent

Pacel(tm) Flow Directed Pacing Catheter

Daig Corp., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914185 is the FDA 510(k) clearance record for PACEL(TM) FLOW DIRECTED PACING CATHETER, a class II device, cleared for Daig Corp. on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 35 510(k) clearances for Daig Corp., from to . As of , FDA records show no recalls naming K914185.

Clearance record

Decision date
Received
(131 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Daig Corp. 14901 Deveau Pl., Minnetonka MN
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