Modification to Securacath, Model: SPK01
FDA 510(k) K083081 · Interrad Medical, Inc.
510(k) numberK083081
Submission
- Device name
- Modification to Securacath, Model: SPK01
- Applicant
- Interrad Medical, Inc.
Plymouth, MN, US - Received
- October 16, 2008
- Decision date
- March 4, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OKC – Implanted Subcutaneous Securement Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5970
- Specialty
- General Hospital
- Implant
- Yes
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.
Other 510(k)s with product code OKC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210629 | SecurAcathOKC · Special | Interrad Medical, Inc. | 04/12/2021SE |
| K180769 | SecurAcathOKC · Special | Interrad Medical, Inc. | 06/26/2018SE |
| K120935 | SecuracathOKC · Special | Interrad Medical, Inc. | 04/27/2012SE |
| K082047 | Securacath Catheter, Model SPK01OKC · Traditional | Interrad Medical, Inc. | 09/30/2008SE |
More from Interrad Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K210629 | SecurAcathOKC · Special | 04/12/2021SE |
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…KMK · Traditional | 07/09/2019SE |
| K180769 | SecurAcathOKC · Special | 06/26/2018SE |
| K120935 | SecuracathOKC · Special | 04/27/2012SE |
| K092306 | Securacath UniversalLJS · Traditional | 07/09/2010SE |
| K082047 | Securacath Catheter, Model SPK01OKC · Traditional | 09/30/2008SE |
Questions and answers
When was Modification to Securacath, Model: SPK01 cleared by the FDA?
Modification to Securacath, Model: SPK01 (K083081) received a 510(k) decision of Substantially Equivalent on March 4, 2009, 139 days after the submission was received.
What is the product code of K083081?
The FDA product code is OKC – Implanted Subcutaneous Securement Catheter, a Class II (moderate risk) device regulated under 21 CFR 880.5970.