510(k) K870419
K870419 is an FDA 510(k) premarket notification submitted by North Coast Medi-Tek for the device "IVR-SP CUSTOM ANGIOGRAPHY TRAY". The FDA issued a decision of Substantially Equivalent on May 11, 1987. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. North Coast Medi-Tek has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1987
- Date Received
- February 3, 1987
- 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