The following data is part of a premarket notification filed by Medsource International with the FDA for Medsource Clearsafe Safety Iv Catheter.
Device ID | K150611 |
510k Number | K150611 |
Device Name: | MedSource ClearSafe Safety IV Catheter |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | MedSource International 4201 Norex Drive Chaska, MN 55318 |
Contact | Laura Riggen |
Correspondent | Laura Riggen MedSource International 4201 Norex Drive Chaska, MN 55318 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-10 |
Decision Date | 2015-07-15 |
Summary: | summary |