The following data is part of a premarket notification filed by Spire Biomedical Inc with the FDA for 15.5 Fr Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, Dfc19sh24, Dfc23sh28, Dfc27sh32, Dfc31sh36, Dfc35sh40.
| Device ID | K063431 |
| 510k Number | K063431 |
| Device Name: | 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | SPIRE BIOMEDICAL INC ONE PATRIOTS PARK Bedford, MA 01730 |
| Contact | Shekhar D Nimkar |
| Correspondent | Shekhar D Nimkar 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 | 2006-11-13 |
| Decision Date | 2007-01-29 |
| Summary: | summary |