510(k) K901625
K901625 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FOGARTY ARTERIAL EMBOLECTOMY II CATHETER". The FDA issued a decision of Substantially Equivalent on Jul 6, 1990. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 6, 1990
- Date Received
- Apr 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Embolectomy
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
- 510(k)