510(k) K945963
K945963 is an FDA 510(k) premarket notification submitted by Micro Interventional Systems, Inc. for the device "THE OMNIGUIDE GUIDING CATHETER WITH BALLOON". The FDA issued a decision of Substantially Equivalent on February 8, 1995. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1995
- Date Received
- December 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Occluder, Catheter Tip
- Device Class
- Class II
- Regulation Number
- 870.1370
- Review Panel
- CV
- Submission Type