510(k) K792141
K792141 is an FDA 510(k) premarket notification submitted by Pharmaseal Div., Baxter Healthcare Corp. for the device "CONTINUOUS FLUSH DEVICE". The FDA issued a decision of Substantially Equivalent on December 5, 1979. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Pharmaseal Div., Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1979
- Date Received
- October 22, 1979
- 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