K003229 is an FDA 510(k) clearance for the BIOPATCH ANTIMICROBIAL DRESSING. This device is classified as a Securement Wound Dressing For Reduction Of Infection.
Submitted by Integra Lifesciences Corp. (Somerville, US). The FDA issued a Cleared decision on October 26, 2001, 381 days after receiving the submission on October 10, 2000.
This device falls under the General & Plastic Surgery FDA review panel. 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)..
| 510(k) Number | K003229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2000 |
| Decision Date | October 26, 2001 |
| Days to Decision | 381 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | SEL — Securement Wound Dressing For Reduction Of Infection |
| Device Class | — |
| 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). |