The following data is part of a premarket notification filed by Orbusneich Medical Trading Inc. with the FDA for Jade Pta Balloon Dilatation Catheter.
| Device ID | K173894 |
| 510k Number | K173894 |
| Device Name: | Jade PTA Balloon Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33309 |
| Contact | John Pazienza |
| Correspondent | John Pazienza OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33309 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2018-02-09 |
| Summary: | summary |