K082047 is an FDA 510(k) clearance for the SECURACATH CATHETER, MODEL SPK01. This device is classified as a Implanted Subcutaneous Securement Catheter (Class II - Special Controls, product code OKC).
Submitted by Interrad Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 30, 2008, 74 days after receiving the submission on July 18, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970. Access To Central Venous System For Blood Sampling And Infusion, And To Provide A Means To Secure The Catheter Via A Subcutaneous Anchor Below The Insertion Site..
| 510(k) Number | K082047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2008 |
| Decision Date | September 30, 2008 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | OKC - Implanted Subcutaneous Securement Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |
| Definition | Access To Central Venous System For Blood Sampling And Infusion, And To Provide A Means To Secure The Catheter Via A Subcutaneous Anchor Below The Insertion Site. |