510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052603Substantially Equivalent

Reprocessed Daig Livewire Electrophysiology Catheters

Alliance Medical Corp., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052603 is the FDA 510(k) clearance record for REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS, a class II device, cleared for Alliance Medical Corp. on under FDA product code NLH (Catheter, Recording, Electrode, Reprocessed). FDA's definition for product code NLH reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". FDA records list 47 510(k) clearances for Alliance Medical Corp., from to . As of , FDA records show 26 recalls naming K052603.

Clearance record

Decision date
Received
(56 days to decision)
Product code
NLH Catheter, Recording, Electrode, Reprocessed
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Alliance Medical Corp. 10232 S. 51st St., Phoenix AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLH

Trailing 12 months
1 clearance under product code NLH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NLH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260