510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242419Substantially Equivalent

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

Creagh Medical Ltd. dba Surmodics, Inc., Ballinasloe, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242419 is the FDA 510(k) clearance record for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter, a class II device, cleared for Creagh Medical Ltd. Dba Surmodics, Inc. on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list one 510(k) clearance for Creagh Medical Ltd. Dba Surmodics, Inc. As of , FDA records show no recalls naming K242419.

Clearance record

Decision date
Received
(92 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Creagh Medical Ltd. Dba Surmodics, Inc. Ida Business Park, Ballinasloe, Ballinasloe, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIT

Trailing 12 months
5 clearances under product code LIT in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LIT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20262
October 20260