The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Clinicath Ir Peripherally Inserted Catheter.
| Device ID | K970269 |
| 510k Number | K970269 |
| Device Name: | CLINICATH IR PERIPHERALLY INSERTED CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-23 |
| Decision Date | 1997-06-26 |
| Summary: | summary |