510(k) K973477
K973477 is an FDA 510(k) premarket notification submitted by Sunscope Intl., Inc. for the device "BIOSENSORS EMBOLECTOMY CATHETER". The FDA issued a decision of Substantially Equivalent on September 4, 1998. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Sunscope Intl., Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1998
- Date Received
- September 15, 1997
- 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