Submission Details
| 510(k) Number | K192493 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 2019 |
| Decision Date | January 24, 2020 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
BD Cathena (TM) Safety IV Catheter
Jan 2020
Decision
135d
Days
Class 2
Risk
About This 510(k) Submission
K192493 is an FDA 510(k) clearance for the BD Cathena (TM) Safety IV Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on January 24, 2020, 135 days after receiving the submission on September 11, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.
Device Classification
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
Manufacturer
Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT · US
Henry Boland
35 submissions
35 cleared
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