510(k) K082736
K082736 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER". The FDA issued a decision of Substantially Equivalent on September 24, 2008. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2008
- Date Received
- September 18, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type