510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K113773Substantially Equivalent

St Jude Medical, Is4 Flushing/funneling Tool

Abbott Medical, Sylmar CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113773 is the FDA 510(k) clearance record for ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL, a class II device, cleared for St Jude Medical on under FDA product code KRA (Catheter, Continuous Flush). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K113773.

Clearance record

Decision date
Received
(27 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
St Jude Medical 15900 Valley View Ct., Sylmar CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRA

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