The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems Inc. with the FDA for Bd Cathena Safety Iv Catheter.
Device ID | K220584 |
510k Number | K220584 |
Device Name: | BD Cathena Safety IV Catheter |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 |
Contact | Paul Holman |
Correspondent | Paul Holman Becton Dickinson Infusion Therapy Systems Inc. 9450 South State Street Sandy, UT 84070 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-01 |
Decision Date | 2022-03-31 |