510(k) K092372
K092372 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "HEARTRAIL III GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on September 11, 2009. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Terumo Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2009
- Date Received
- August 5, 2009
- 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