SEL · Securement Wound Dressing For Reduction Of Infection
· Class U
Overview
| Product Code | SEL |
|---|---|
| Device Name | Securement Wound Dressing For Reduction Of Infection |
| Device Class | Class U |
| Review Panel |
Identification
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).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171908 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 3M Company | Jul 11, 2017 | SESE |
| K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | 3M Company | May 15, 2017 | SESE |
| K003229 | BIOPATCH ANTIMICROBIAL DRESSING | Integra Lifesciences Corp. | Oct 26, 2001 | SESE |
Top Applicants
- 3M Company — 2 clearances
- Integra Lifesciences Corp. — 1 clearance
