The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Central Venous Multi-lumen Catheters And Kits.
| Device ID | K871573 |
| 510k Number | K871573 |
| Device Name: | CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS |
| Classification | Catheter, Percutaneous |
| Applicant | SPECTRAMED, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy SPECTRAMED, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-22 |
| Decision Date | 1987-09-16 |