The following data is part of a premarket notification filed by Rymed Technologies, Inc. with the FDA for In Vision-plus Nano With Neutral Advantage Technology.
| Device ID | K093489 |
| 510k Number | K093489 |
| Device Name: | IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY |
| Classification | Set, Administration, Intravascular |
| Applicant | RYMED TECHNOLOGIES, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary RYMED TECHNOLOGIES, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-11-10 |
| Decision Date | 2010-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817903010746 | K093489 | 000 |
| 20817903010104 | K093489 | 000 |
| 20817903010074 | K093489 | 000 |
| 20817903010029 | K093489 | 000 |
| 20817903010852 | K093489 | 000 |
| 20817903010845 | K093489 | 000 |
| 20817903010838 | K093489 | 000 |
| 30817903010705 | K093489 | 000 |
| 30817903010675 | K093489 | 000 |