BD Centro Vena Acute Central Line (7 French Dual Lumen)
FDA 510(k) clearance K200266 · decided 2020-04-07
Clearance details
- K-number
- K200266
- Device name
- BD Centro Vena Acute Central Line (7 French Dual Lumen)
- Applicant
- Bard Access Systems, Inc. (Bard Has Joined Bd)
- Decision
- Substantially Equivalent
- Date received
- 2020-02-03
- Decision date
- 2020-04-07
- Days to decision
- 64 days
- Clearance type
- Special
- 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
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.