The following data is part of a premarket notification filed by Spire Biomedical Inc with the FDA for 15.5fr Alta Gold, Coated Hemodialysis Catheter, Model Alc19sh24, Alc23sh28, Alc27sh32, Alc31sh36, Alc35sh40, Alc50sh55.
| Device ID | K063441 |
| 510k Number | K063441 |
| Device Name: | 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | SPIRE BIOMEDICAL INC ONE PATRIOTS PARK Bedford, MA 01730 |
| Contact | Shekhar Nimkar |
| Correspondent | Shekhar 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 | Yes |
| Date Received | 2006-11-14 |
| Decision Date | 2007-02-12 |
| Summary: | summary |