510(k) K812326
K812326 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "SORENSON SUBCLAVIAN CATHETER SSC-8". The FDA issued a decision of Substantially Equivalent on September 25, 1981. The device falls under product code LFJ (Catheter, Subclavian), a Class II device regulated under 21 CFR 876.5540. Sorensen Research has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1981
- Date Received
- August 17, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Subclavian
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type