510(k) K902477
K902477 is an FDA 510(k) premarket notification submitted by Medical Engineering and Development Institute for the device "WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET". The FDA issued a decision of Substantially Equivalent on August 24, 1990. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medical Engineering and Development Institute has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1990
- Date Received
- June 4, 1990
- 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