BD Intima II PLUS Closed IV Catheter System
FDA 510(k) clearance K172204 · decided 2017-08-17
Clearance details
- K-number
- K172204
- Device name
- BD Intima II PLUS Closed IV Catheter System
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2017-07-21
- Decision date
- 2017-08-17
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sandy, UT, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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