510(k) K153410
K153410 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing". The FDA issued a decision of Substantially Equivalent on May 15, 2017. The device falls under product code SEL (Securement Wound Dressing For Reduction Of Infection), a Class U device. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2017
- Date Received
- November 25, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Securement Wound Dressing For Reduction Of Infection
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
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 insertion site and reduce the incidence of catheter-related bloodstream infections (CRBSI).