Securement Wound Dressing For Reduction Of Infection
Basic Information
- Product Code
- SEL
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
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).
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K171908 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | Jul 11, 2017 | Substantially Equivalent | 3M Company |
| K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing | May 15, 2017 | Substantially Equivalent | 3M Company |
| K003229 | BIOPATCH ANTIMICROBIAL DRESSING | Oct 26, 2001 | Substantially Equivalent | Integra Lifesciences Corp. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.