The following data is part of a premarket notification filed by Biotronik, Inc with the FDA for Multicath, Acqrate Dx Fixed Curve Catheter.
| Device ID | K201445 |
| 510k Number | K201445 |
| Device Name: | MultiCath, AcQRate Dx Fixed Curve Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Biotronik, Inc 6024 Jean Road Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh Biotronik, Inc 6024 Jean Road Lake Oswego, OR 97035 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2021-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260090928967 | K201445 | 000 |
| 04260090928783 | K201445 | 000 |
| 04260090928776 | K201445 | 000 |
| 04260090928769 | K201445 | 000 |
| 04260090928752 | K201445 | 000 |
| 04260090928745 | K201445 | 000 |
| 04260090928738 | K201445 | 000 |
| 04260090928721 | K201445 | 000 |
| 04260090928714 | K201445 | 000 |
| 04035479092436 | K201445 | 000 |
| 04260090928851 | K201445 | 000 |
| 04260090928868 | K201445 | 000 |
| 04260090928950 | K201445 | 000 |
| 04260090928943 | K201445 | 000 |
| 04260090928936 | K201445 | 000 |
| 04260090928929 | K201445 | 000 |
| 04260090928912 | K201445 | 000 |
| 04260090928905 | K201445 | 000 |
| 04260090928899 | K201445 | 000 |
| 04260090928882 | K201445 | 000 |
| 04260090928875 | K201445 | 000 |
| 04035479092429 | K201445 | 000 |