The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Oscar Peripheral Multifunctional Catheter System.
| Device ID | K214038 |
| 510k Number | K214038 |
| Device Name: | Oscar Peripheral Multifunctional Catheter System |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-23 |
| Decision Date | 2022-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640130455801 | K214038 | 000 |
| 07640130455689 | K214038 | 000 |
| 07640130455672 | K214038 | 000 |
| 07640130455665 | K214038 | 000 |
| 07640130455658 | K214038 | 000 |
| 07640130455641 | K214038 | 000 |
| 07640130455634 | K214038 | 000 |
| 07640130455627 | K214038 | 000 |
| 07640130455610 | K214038 | 000 |
| 07640130455603 | K214038 | 000 |
| 07640130455696 | K214038 | 000 |
| 07640130455702 | K214038 | 000 |
| 07640130455795 | K214038 | 000 |
| 07640130455788 | K214038 | 000 |
| 07640130455771 | K214038 | 000 |
| 07640130455764 | K214038 | 000 |
| 07640130455757 | K214038 | 000 |
| 07640130455740 | K214038 | 000 |
| 07640130455733 | K214038 | 000 |
| 07640130455726 | K214038 | 000 |
| 07640130455719 | K214038 | 000 |
| 07640130455597 | K214038 | 000 |