The following data is part of a premarket notification filed by Northeast Scientific, Inc. with the FDA for Nes Reprocessed Visions Pv .014p Rx Digital Ivus Catheter.
| Device ID | K200195 |
| 510k Number | K200195 |
| Device Name: | NES Reprocessed Visions PV .014P RX Digital IVUS Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Northeast Scientific, Inc. 2142 Thomaston Ave. Waterbury, CT 06704 |
| Contact | Matthew Farley |
| Correspondent | Matthew Farley Northeast Scientific, Inc. 2142 Thomaston Ave. Waterbury, CT 06704 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-27 |
| Decision Date | 2020-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| NRP014 | K200195 | 000 |
| B227NRP0140 | K200195 | 000 |
| 57613327664084 | K200195 | 000 |