The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Sims Deltec, Inc. Catheter Replacement Connector.
| Device ID | K950284 |
| 510k Number | K950284 |
| Device Name: | SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa J Stone |
| Correspondent | Lisa J 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 | 1995-01-24 |
| Decision Date | 1995-05-23 |