510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K891005Substantially Equivalent

Intravascular Admini. Set Models 60030 & 60050

3M Company, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891005 is the FDA 510(k) clearance record for INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050, a class II device, cleared for 3M Company on under FDA product code FPK (Tubing, Fluid Delivery). FDA records list 146 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming K891005.

Clearance record

Decision date
Received
(72 days to decision)
Product code
FPK Tubing, Fluid Delivery
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
3M Company 1120 Red Fox Rd., St. Paul MN
Third party review
No

Clearances, product code FPK

Trailing 12 months

FDA records hold no clearances under product code FPK in the trailing twelve months.

FDA records show no clearances under product code FPK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260