The following data is part of a premarket notification filed by B. Braun Interventional Systems Inc. with the FDA for Sequent Neo Percutaneous Transluminal Coronary Angioplasty (ptca) Balloon Catheters.
| Device ID | K162625 |
| 510k Number | K162625 |
| Device Name: | SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | B. BRAUN INTERVENTIONAL SYSTEMS INC. 824 TWELFTH AVENUE Bethlehem, PA 18018 |
| Contact | Peter Flosdorf |
| Correspondent | Peter Flosdorf B. BRAUN INTERVENTIONAL SYSTEMS INC. 824 TWELFTH AVENUE Bethlehem, PA 18018 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-20 |
| Decision Date | 2017-06-12 |
| Summary: | summary |