K083081 is an FDA 510(k) clearance for the MODIFICATION TO SECURACATH, 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 March 4, 2009, 139 days after receiving the submission on October 16, 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 | K083081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2008 |
| Decision Date | March 04, 2009 |
| Days to Decision | 139 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. |