510(k) K920331
K920331 is an FDA 510(k) premarket notification submitted by Akcess Medical Products, Inc. for the device "RIGHT ATRIAL CATHETER KITS". The FDA issued a decision of Substantially Equivalent (kit) on April 22, 1992. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Akcess Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- April 22, 1992
- Date Received
- January 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type