The following data is part of a premarket notification filed by Biotronik, Inc with the FDA for Pantera Pro.
| Device ID | K160985 |
| 510k Number | K160985 |
| Device Name: | Pantera Pro |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| 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 | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-08 |
| Decision Date | 2016-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640130437258 | K160985 | 000 |
| 07640130437074 | K160985 | 000 |
| 07640130437067 | K160985 | 000 |
| 07640130437050 | K160985 | 000 |
| 07640130437043 | K160985 | 000 |
| 07640130437036 | K160985 | 000 |
| 07640130437029 | K160985 | 000 |
| 07640130437012 | K160985 | 000 |
| 07640130437005 | K160985 | 000 |
| 07640130436992 | K160985 | 000 |
| 07640130436985 | K160985 | 000 |
| 07640130436978 | K160985 | 000 |
| 07640130436961 | K160985 | 000 |
| 07640130436954 | K160985 | 000 |
| 07640130436947 | K160985 | 000 |
| 07640130437081 | K160985 | 000 |
| 07640130437098 | K160985 | 000 |
| 07640130437104 | K160985 | 000 |
| 07640130437241 | K160985 | 000 |
| 07640130437234 | K160985 | 000 |
| 07640130437227 | K160985 | 000 |
| 07640130437210 | K160985 | 000 |
| 07640130437203 | K160985 | 000 |
| 07640130437197 | K160985 | 000 |
| 07640130437180 | K160985 | 000 |
| 07640130437173 | K160985 | 000 |
| 07640130437166 | K160985 | 000 |
| 07640130437159 | K160985 | 000 |
| 07640130437142 | K160985 | 000 |
| 07640130437135 | K160985 | 000 |
| 07640130437128 | K160985 | 000 |
| 07640130437111 | K160985 | 000 |
| 07640130436930 | K160985 | 000 |