3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
FDA 510(k) K153410 · 3M Company
510(k) numberK153410
Submission
- Device name
- 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
- Applicant
- 3M Company
St. Paul, MN, US - Received
- November 25, 2015
- Decision date
- May 15, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SEL – Securement Wound Dressing For Reduction Of Infection
- Device class
- Unclassified
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 to secure central venous or arterial catheters, a securement wound dressing for reduction of infection is intended to reduce microbial colonization around the…
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Questions and answers
When was 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing cleared by the FDA?
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K153410) received a 510(k) decision of Substantially Equivalent on May 15, 2017, 537 days after the submission was received.
What is the product code of K153410?
The FDA product code is SEL – Securement Wound Dressing For Reduction Of Infection, a Unclassified device.