The following data is part of a premarket notification filed by Deltec Systems, Inc. with the FDA for Pharmacia Deltec Subclavian Introducers.
| Device ID | K871132 |
| 510k Number | K871132 |
| Device Name: | PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS |
| Classification | Introducer, Catheter |
| Applicant | DELTEC SYSTEMS, INC. 1265 GREY FOX RD. St Paul, MN 55112 |
| Contact | W Numainville |
| Correspondent | W Numainville DELTEC SYSTEMS, INC. 1265 GREY FOX RD. St Paul, MN 55112 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-20 |
| Decision Date | 1987-04-20 |