510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153410Substantially Equivalent

3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

3M Company, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153410 is the FDA 510(k) clearance record for 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing, cleared for 3M Company on under FDA product code SEL (Securement Wound Dressing For Reduction Of Infection). FDA's definition for product code SEL reads: "These dressings are intended to be placed over a vascular or percutaneous device (e.g., needle, catheter, drain) to keep it securely anchored to the skin, cover and protect the insertion site, and may additionally absorb exudate. When used...". FDA records list 146 510(k) clearances for 3M Company, from to . As of , FDA records show one recall naming K153410.

Clearance record

Decision date
Received
(537 days to decision)
Product code
SEL Securement Wound Dressing For Reduction Of Infection
Device class
Unclassified
Review panel
Unknown
Applicant
3M Company 3m Center, St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SEL

Trailing 12 months

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

FDA records show no clearances under product code SEL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SEL, 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