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 |