The following data is part of a premarket notification filed by Rapid-medical Ltd. with the FDA for Columbus Guidewire.
| Device ID | K200374 |
| 510k Number | K200374 |
| Device Name: | Columbus Guidewire |
| Classification | Guide, Wire, Catheter, Neurovasculature |
| Applicant | Rapid-Medical Ltd. Carmel Building, POB 337 Yokneam, IL 2069205 |
| Contact | Orit Yaniv |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | MOF |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-14 |
| Decision Date | 2020-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290015107242 | K200374 | 000 |
| 07290015107235 | K200374 | 000 |