510(k) K021142
K021142 is an FDA 510(k) premarket notification submitted by Fortune Medical Instrument Corp. for the device "ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865". The FDA issued a decision of Substantially Equivalent on October 1, 2002. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Fortune Medical Instrument Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2002
- Date Received
- April 9, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type