510(k) K894883
K894883 is an FDA 510(k) premarket notification submitted by Vitaid, Ltd. for the device "PHYCON ALL SILICONE BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on Apr 25, 1990. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Vitaid, Ltd. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 25, 1990
- Date Received
- Aug 1, 1989
- 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
- 510(k)