The following data is part of a premarket notification filed by Creagh Medical Ltd. with the FDA for Surmodics Sublime Radial Access 014 Rx Pta (percutaneous Transluminal Angioplasty) Dilatation Catheter.
| Device ID | K200700 |
| 510k Number | K200700 |
| Device Name: | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Creagh Medical Ltd. IDA Business Park Ballinasloe, IE H53 Hy09 |
| Contact | Amy Yanta |
| Correspondent | Amy Yanta Creagh Medical Ltd. 9924 W 74th St Eden Prairie, MN 55344 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-17 |
| Decision Date | 2020-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391525783789 | K200700 | 000 |
| 05391525783949 | K200700 | 000 |
| 05391525783932 | K200700 | 000 |
| 05391525783925 | K200700 | 000 |
| 05391525783918 | K200700 | 000 |
| 05391525783901 | K200700 | 000 |
| 05391525783895 | K200700 | 000 |
| 05391525783888 | K200700 | 000 |
| 05391525783871 | K200700 | 000 |
| 05391525783864 | K200700 | 000 |
| 05391525783857 | K200700 | 000 |
| 05391525783840 | K200700 | 000 |
| 05391525783833 | K200700 | 000 |
| 05391525783826 | K200700 | 000 |
| 05391525783819 | K200700 | 000 |
| 05391525783802 | K200700 | 000 |
| 05391525783956 | K200700 | 000 |
| 05391525783963 | K200700 | 000 |
| 05391525783772 | K200700 | 000 |
| 05391525783765 | K200700 | 000 |
| 05391525783758 | K200700 | 000 |
| 05391525783741 | K200700 | 000 |
| 05391525783734 | K200700 | 000 |
| 05391525783727 | K200700 | 000 |
| 05391525783710 | K200700 | 000 |
| 05391525783703 | K200700 | 000 |
| 05391525783697 | K200700 | 000 |
| 05391525783680 | K200700 | 000 |
| 05391525783666 | K200700 | 000 |
| 05391525783659 | K200700 | 000 |
| 05391525783642 | K200700 | 000 |
| 05391525783635 | K200700 | 000 |
| 05391525783628 | K200700 | 000 |
| 05391525783796 | K200700 | 000 |