510(k) K003229
K003229 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "BIOPATCH ANTIMICROBIAL DRESSING". The FDA issued a decision of Substantially Equivalent on Oct 26, 2001. The device falls under product code SEL (Securement Wound Dressing For Reduction Of Infection), a Class U device. Integra Lifesciences Corp. has 28 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 26, 2001
- Date Received
- Oct 10, 2000
- 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
- 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).