K171908 is an FDA 510(k) clearance for the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing. This device is classified as a Securement Wound Dressing For Reduction Of Infection.
Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on July 11, 2017, 15 days after receiving the submission on June 26, 2017.
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 | K171908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2017 |
| Decision Date | July 11, 2017 |
| Days to Decision | 15 days |
| Submission Type | Special |
| 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). |