The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Percutaneous Intravenous Catheter Repair Kit.
| Device ID | K904334 |
| 510k Number | K904334 |
| Device Name: | PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Edward Numainville |
| Correspondent | Edward Numainville PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-21 |
| Decision Date | 1990-11-05 |