510(k) K152952
K152952 is an FDA 510(k) premarket notification submitted by PAJUNK GmbH Medizintechnologie for the device "E-Cath". The FDA issued a decision of Substantially Equivalent on July 13, 2016. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. PAJUNK GmbH Medizintechnologie has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2016
- Date Received
- October 6, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Conduction, Anesthetic
- Device Class
- Class II
- Regulation Number
- 868.5120
- Review Panel
- AN
- Submission Type