The following data is part of a premarket notification filed by Medcomp (medical Components, Inc.) with the FDA for Celerity Sysyem.
| Device ID | K140799 |
| 510k Number | K140799 |
| Device Name: | CELERITY SYSYEM |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDCOMP (MEDICAL COMPONENTS, INC.) 25 FOREST DRIVE Marlborough, MA 01752 |
| Contact | Lorraine M Hanley |
| Correspondent | Lorraine M Hanley MEDCOMP (MEDICAL COMPONENTS, INC.) 25 FOREST DRIVE Marlborough, MA 01752 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-31 |
| Decision Date | 2014-06-13 |
| Summary: | summary |