510(k) K132619
K132619 is an FDA 510(k) premarket notification submitted by Flexicare Medical, Ltd. for the device "CLASSIC INTERMITTENT CATHETER". The FDA issued a decision of Substantially Equivalent on October 11, 2013. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Flexicare Medical, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2013
- Date Received
- August 21, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type