510(k) K802830
K802830 is an FDA 510(k) premarket notification submitted by Millar Instruments, Inc. for the device "MILLAR MIKRO-TIP CATHETER PHONOTRANS". The FDA issued a decision of Substantially Equivalent on December 10, 1980. The device falls under product code DXW (System, Phonocatheter, Intracavitary), a Class II device regulated under 21 CFR 870.1270. Millar Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1980
- Date Received
- November 10, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Phonocatheter, Intracavitary
- Device Class
- Class II
- Regulation Number
- 870.1270
- Review Panel
- CV
- Submission Type