The following data is part of a premarket notification filed by Pavmed, Inc. with the FDA for Carpx.
Device ID | K200559 |
510k Number | K200559 |
Device Name: | CarpX |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | PAVmed, Inc. New York, NY 10165 |
Contact | Lishan Aklog |
Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-03 |
Decision Date | 2020-04-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860004588009 | K200559 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARPX 87828085 not registered Live/Pending |
PAVmed Inc. 2018-03-09 |