510(k) K844854
K844854 is an FDA 510(k) premarket notification submitted by Vas-Cath of Canada , Ltd. for the device "OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT". The FDA issued a decision of Substantially Equivalent on May 21, 1985. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Vas-Cath of Canada , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1985
- Date Received
- December 13, 1984
- 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