510(k) K090576
K090576 is an FDA 510(k) premarket notification submitted by Footprint Medical for the device "FOOTPRINT URINARY DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on August 12, 2009. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Footprint Medical has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2009
- Date Received
- March 3, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type