510(k) K905463
K905463 is an FDA 510(k) premarket notification submitted by Angiosystems, Inc. for the device "GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION". The FDA issued a decision of Substantially Equivalent (kit, denovo) on January 22, 1991. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Angiosystems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- January 22, 1991
- Date Received
- December 5, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type