510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842113Substantially Equivalent

Amendment to Angiography Kit W/addit

Mallinckrodt Critical Care, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842113 is the FDA 510(k) clearance record for AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT, a class II device, cleared for Mallinckrodt Critical Care on under FDA product code DRE (Dilator, Vessel, For Percutaneous Catheterization). FDA records list 92 510(k) clearances for Mallinckrodt Critical Care, from to . As of , FDA records show no recalls naming K842113.

Clearance record

Decision date
Received
(116 days to decision)
Product code
DRE Dilator, Vessel, For Percutaneous Catheterization
Regulation
21 CFR 870.1310
Device class
Class II
Review panel
Cardiovascular
Applicant
Mallinckrodt Critical Care 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DRE

Trailing 12 months
2 clearances under product code DRE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260