510(k) K883651
K883651 is an FDA 510(k) premarket notification submitted by Millar Instruments, Inc. for the device "MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on November 18, 1988. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Millar Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1988
- Date Received
- August 26, 1988
- 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