510(k) K844918
K844918 is an FDA 510(k) premarket notification submitted by Clincal Instruments Corp. for the device "OCCLUSION & OCCLUSION-IRRIGATION". The FDA issued a decision of Substantially Equivalent on August 5, 1985. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370. Clincal Instruments Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1985
- Date Received
- December 19, 1984
- 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