510(k) K892410
K892410 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER". The FDA issued a decision of Substantially Equivalent on Jul 20, 1989. 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 20, 1989
- Date Received
- Apr 7, 1989
- 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)