The following data is part of a premarket notification filed by Microvasive with the FDA for Inflator/deflator Piston Syringe.
| Device ID | K860589 |
| 510k Number | K860589 |
| Device Name: | INFLATOR/DEFLATOR PISTON SYRINGE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Contact | Samuel D Wade |
| Correspondent | Samuel D Wade MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-04-07 |