BD Acute Central Line
FDA 510(k) clearance K190855 · decided 2019-11-01
Clearance details
- K-number
- K190855
- Device name
- BD Acute Central Line
- Applicant
- Bard Access Systems, Inc. (Bard Has Joined Bd)
- Decision
- Substantially Equivalent
- Date received
- 2019-04-02
- Decision date
- 2019-11-01
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake Ciy,, UT, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.