510(k) K040519
K040519 is an FDA 510(k) premarket notification submitted by Percutaneous Systems, Inc. for the device "SLIP UROLOGY CATHETER". The FDA issued a decision of Substantially Equivalent on May 20, 2004. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Percutaneous Systems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2004
- Date Received
- February 27, 2004
- 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