510(k) K911184
K911184 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN/TAHERI VALVULOTOME". The FDA issued a decision of Substantially Equivalent on February 18, 1992. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1992
- Date Received
- March 18, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Valvulotome
- Device Class
- Class II
- Regulation Number
- 870.4885
- Review Panel
- CV
- Submission Type