The following data is part of a premarket notification filed by Spire Biomedical Inc with the FDA for Decathlon Twin Lumen Hemodialysis Catheter With Separated Tips, Models De19sh24, De23sh28, De27sh32, De31sh36, De35sh40,.
| Device ID | K073092 |
| 510k Number | K073092 |
| Device Name: | DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | SPIRE BIOMEDICAL INC ONE PATRIOTS PARK Bedford, MA 01730 |
| Contact | Raymond Kelly |
| Correspondent | Raymond Kelly SPIRE BIOMEDICAL INC ONE PATRIOTS PARK Bedford, MA 01730 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-01 |
| Decision Date | 2008-01-29 |
| Summary: | summary |