The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Advantiv Safety I.v. Catheter.
| Device ID | K072419 |
| 510k Number | K072419 |
| Device Name: | ADVANTIV SAFETY I.V. CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin, OH 43016 |
| Contact | Barbara Law |
| Correspondent | Barbara Law SMITHS MEDICAL ASD, INC. 6250 SHIER RINGS RD. Dublin, OH 43016 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-28 |
| Decision Date | 2007-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688063780 | K072419 | 000 |
| 30351688063773 | K072419 | 000 |
| 30351688063759 | K072419 | 000 |