The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Clinicath Polyflow Polyurethane Peripherally Inserted Catheters.
| Device ID | K984055 |
| 510k Number | K984055 |
| Device Name: | CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-13 |
| Decision Date | 1999-01-29 |
| Summary: | summary |