510(k) K905139
K905139 is an FDA 510(k) premarket notification submitted by Cathlab Corp. for the device "CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER". The FDA issued a decision of Substantially Equivalent on February 25, 1991. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Cathlab Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1991
- Date Received
- November 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