Implanted Subcutaneous Securement Catheter
The Implanted Subcutaneous Securement Catheter is an implantable device that provides access to the central venous system for blood sampling and infusion, while also incorporating a subcutaneous anchor below the insertion site to secure the catheter in place and reduce displacement or dislodgement. Classified as FDA Class 2 under regulation 21 CFR 880.5970 within the General Hospital medical specialty, it requires a 510(k) premarket notification. The product code is OKC. It is flagged as an implant device.
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Basic Information
- Product Code
- OKC
- Device Class
- FDA class 2
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K210629 | SecurAcath | Apr 12, 2021 | Substantially Equivalent | Interrad Medical, Inc. |
| K180769 | SecurAcath | Jun 26, 2018 | Substantially Equivalent | Interrad Medical, Inc. |
| K120935 | SECURACATH | Apr 27, 2012 | Substantially Equivalent | Interrad Medical, Inc. |
| K083081 | MODIFICATION TO SECURACATH, MODEL: SPK01 | Mar 04, 2009 | Substantially Equivalent | Interrad Medical, Inc. |
| K082047 | SECURACATH CATHETER, MODEL SPK01 | Sep 30, 2008 | Substantially Equivalent | Interrad Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.