510(k) K900125
K900125 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ARTERIOVENOUS FISTULA SETS". The FDA issued a decision of Substantially Equivalent on Jan 31, 1990. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 31, 1990
- Date Received
- Jan 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Needle, Fistula
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
- 510(k)