The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Viavalve Safety Iv Catheter.
| Device ID | K113700 |
| 510k Number | K113700 |
| Device Name: | VIAVALVE SAFETY IV CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SMITHS MEDICAL ASD, INC. 201 WEST QUEEN ST. Southington, CT 06489 |
| Contact | Brian Farias |
| Correspondent | Brian Farias SMITHS MEDICAL ASD, INC. 201 WEST QUEEN ST. Southington, CT 06489 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688077859 | K113700 | 000 |
| 50351688077453 | K113700 | 000 |
| 50351688077446 | K113700 | 000 |
| 50351688077439 | K113700 | 000 |
| 30351688077428 | K113700 | 000 |
| 30351688077411 | K113700 | 000 |
| 50351688077408 | K113700 | 000 |