510(k) K926374
K926374 is an FDA 510(k) premarket notification submitted by Akcess Medical Products, Inc. for the device "SILICONE CATHETER REPAIR KITS". The FDA issued a decision of Substantially Equivalent (kit) on October 7, 1994. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Akcess Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- October 7, 1994
- Date Received
- December 22, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type