The following data is part of a premarket notification filed by Natec Medical Ltd with the FDA for Ebony Pta 0.035 Peripheral Dilatation Catheter.
Device ID | K143036 |
510k Number | K143036 |
Device Name: | Ebony PTA 0.035 Peripheral Dilatation Catheter |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | Natec Medical Ltd Maeva Centre Building Ebene Business Park Reduit, MU 72201 |
Contact | Xavier De Buchere |
Correspondent | Judith Danielson CardioMed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, MD 21228 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-22 |
Decision Date | 2015-03-30 |
Summary: | summary |