OKC — Implanted Subcutaneous Securement Catheter Class II
Classification Details
- Product Code
- OKC
- Device Class
- Class II
- Regulation Number
- 880.5970
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K210629 | interrad medical | SecurAcath | April 12, 2021 |
| K180769 | interrad medical | SecurAcath | June 26, 2018 |
| K120935 | interrad medical | SECURACATH | April 27, 2012 |
| K083081 | interrad medical | MODIFICATION TO SECURACATH, MODEL: SPK01 | March 4, 2009 |
| K082047 | interrad medical | SECURACATH CATHETER, MODEL SPK01 | September 30, 2008 |