510(k) K853625
K853625 is an FDA 510(k) premarket notification submitted by Nova Medical Specialties for the device "NOVA ARTERIAL EMBOLECTOMY CATHETER". The FDA issued a decision of Substantially Equivalent on January 15, 1986. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Nova Medical Specialties has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 1986
- Date Received
- August 29, 1985
- 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