The following data is part of a premarket notification filed by Ferrosan Medical Devices Sp. Z O.o. with the FDA for Certa Catheter.
| Device ID | K171193 |
| 510k Number | K171193 |
| Device Name: | Certa Catheter |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | Ferrosan Medical Devices SP. Z O.O. Koksowa 3 Szczecin, PL 70-031 |
| Contact | Elzbieta Porebska-guillemant |
| Correspondent | Paul Dryden Ferrosan Medical Devices SP. Z.O.O. C/o Promedic LLC 24301 Woodsage Dr. Bonita Springs, FL 34134 -2958 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-24 |
| Decision Date | 2017-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05902194190466 | K171193 | 000 |
| 05902194190435 | K171193 | 000 |
| 05902194190404 | K171193 | 000 |
| 05902194190374 | K171193 | 000 |
| 05902194190343 | K171193 | 000 |
| 05902194190312 | K171193 | 000 |