510(k) K840437
K840437 is an FDA 510(k) premarket notification submitted by Renal Systems, Inc. for the device "HEMASITE ACCESSORIES MODIFICATION". The FDA issued a decision of Substantially Equivalent on February 21, 1984. The device falls under product code KNZ (Accessories, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Renal Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1984
- Date Received
- February 1, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, A-V Shunt
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type