510(k) K885281
K885281 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION". The FDA issued a decision of Substantially Equivalent on Mar 3, 1989. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 1989
- Date Received
- Dec 27, 1988
- 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
- 510(k)