510(k) K171908
K171908 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 Jul 11, 2017. The device falls under product code SEL (Securement Wound Dressing For Reduction Of Infection), a Class U device. 3M Company has 334 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 11, 2017
- Date Received
- Jun 26, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Securement Wound Dressing For Reduction Of Infection
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)
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).