510(k) K123311
K123311 is an FDA 510(k) premarket notification submitted by Qxmedical, LLC for the device "QXMEDICAL ACCESS & SUPPORT CATHETER". The FDA issued a decision of Substantially Equivalent on January 14, 2013. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Qxmedical, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2013
- Date Received
- October 25, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type