510(k) K031346
K031346 is an FDA 510(k) premarket notification submitted by Jomed, Inc. for the device "JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900". The FDA issued a decision of Substantially Equivalent on June 23, 2003. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200. Jomed, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2003
- Date Received
- April 29, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ultrasound, Intravascular
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.