510(k) K801173
K801173 is an FDA 510(k) premarket notification submitted by Hospital Products Co. for the device "ANGIO-FLO MONITORING KIT". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Hospital Products Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1980
- Date Received
- May 16, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type