510(k) K905042
K905042 is an FDA 510(k) premarket notification submitted by Rochester Medical Corp. for the device "COMFORT SLEEVED ALL SILICONE FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on January 18, 1991. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Rochester Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1991
- Date Received
- November 7, 1990
- 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