OKC
5 FDA 510(k) clearances · Product code
74 daysmedian time to decision
139 days90th percentile
5clearances measured
FDA profile
- Official device name
- Implanted Subcutaneous Securement Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5970
- Medical specialty
- General Hospital
- Flags
- Implant
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SecurAcath (K210629) | Interrad Medical, Inc. | 2021-04-12 |
| SecurAcath (K180769) | Interrad Medical, Inc. | 2018-06-26 |
| SECURACATH (K120935) | Interrad Medical, Inc. | 2012-04-27 |
| MODIFICATION TO SECURACATH, MODEL: SPK01 (K083081) | Interrad Medical, Inc. | 2009-03-04 |
| SECURACATH CATHETER, MODEL SPK01 (K082047) | Interrad Medical, Inc. | 2008-09-30 |
Track OKC automatically
Every clearance here is in the API, with alerts when new ones post.