510(k) K992631
K992631 is an FDA 510(k) premarket notification submitted by Acuson Corp. for the device "ACUNAV DIAGNOSTIC ULTRASOUND CATHETER". The FDA issued a decision of Substantially Equivalent on December 15, 1999. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Acuson Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1999
- Date Received
- August 6, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type