510(k) K933522
K933522 is an FDA 510(k) premarket notification submitted by Mediziv Medical Products 1987 , Ltd. for the device "INTRODUCER NEEDLE (SEVERAL SIZES)". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Mediziv Medical Products 1987 , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1995
- Date Received
- July 20, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type