510(k) K083081
K083081 is an FDA 510(k) premarket notification submitted by Interrad Medical, Inc. for the device "MODIFICATION TO SECURACATH, MODEL: SPK01". The FDA issued a decision of Substantially Equivalent on March 4, 2009. The device falls under product code OKC (Implanted Subcutaneous Securement Catheter), a Class II device regulated under 21 CFR 880.5970. Interrad Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2009
- Date Received
- October 16, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implanted Subcutaneous Securement Catheter
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type
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.