The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Viavalve Safety I.v. Catheter.
| Device ID | K160235 |
| 510k Number | K160235 |
| Device Name: | ViaValve Safety I.V. Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SMITHS MEDICAL ASD, INC. 201 WEST QUEEN STREET Southington, CT 06489 |
| Contact | Brian Farias |
| Correspondent | Brian Farias SMITHS MEDICAL ASD, INC. 201 WEST QUEEN STREET 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 | 2016-02-01 |
| Decision Date | 2016-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817517020762 | K160235 | 000 |
| 55019517078433 | K160235 | 000 |
| 55019517078426 | K160235 | 000 |
| 35019517078415 | K160235 | 000 |
| 35019517078408 | K160235 | 000 |
| 55019517078396 | K160235 | 000 |
| 35019517078385 | K160235 | 000 |
| 35019517078378 | K160235 | 000 |