The following data is part of a premarket notification filed by Spire Biomedical Inc with the FDA for Decathlon Gold Twin Lumen Hemodialysis Catheter With Separated Tips, Models Dec19sh24, Dec23sh28, Dec23sh32, Dec31sh36,.
| Device ID | K073093 |
| 510k Number | K073093 |
| Device Name: | DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, |
| 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 | 2008-01-22 |
| Summary: | summary |