The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Intravascular (i-v) Admininistration Set (dvgenpers Fpa).
| Device ID | K952160 |
| 510k Number | K952160 |
| Device Name: | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688509848 | K952160 | 000 |
| 50351688509763 | K952160 | 000 |
| 50351688509664 | K952160 | 000 |
| 50351688509510 | K952160 | 000 |
| 50351688509824 | K952160 | 000 |
| 50351688509749 | K952160 | 000 |