510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K211044Substantially Equivalent

Sublime Radial Access 018 RX Dilatation Catheter

Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, Ballinasloe, IE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211044 is the FDA 510(k) clearance record for Sublime Radial Access 018 RX Dilatation Catheter, a class II device, cleared for Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list one 510(k) clearance for Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,. As of , FDA records show no recalls naming K211044.

Clearance record

Decision date
Received
(69 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. (A Wholly Owned Subsidiary of Surmodics, Inc), 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