510(k) K831801
K831801 is an FDA 510(k) premarket notification submitted by Exo, Inc. for the device "HEMOCLAV VENOUS CATHETER". The FDA issued a decision of Substantially Equivalent on July 7, 1983. The device falls under product code FIQ (Cannula, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Exo, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 1983
- Date Received
- June 3, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, A-V Shunt
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type