510(k) K992368
K992368 is an FDA 510(k) premarket notification submitted by Vascutech, Inc. for the device "LEMAITRE EMBOLECTOMY CATHETER". The FDA issued a decision of Substantially Equivalent on December 9, 1999. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Vascutech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1999
- Date Received
- July 15, 1999
- 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