510(k) K880231
K880231 is an FDA 510(k) premarket notification submitted by Ideas For Medicine, Inc. for the device "MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER". The FDA issued a decision of Substantially Equivalent on May 25, 1988. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370. Ideas For Medicine, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 1988
- Date Received
- January 13, 1988
- 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