PICC Maximal Barrier Nursing Kit
FDA 510(k) clearance K163452 · decided 2017-02-03
Clearance details
- K-number
- K163452
- Device name
- PICC Maximal Barrier Nursing Kit
- Applicant
- Navilyst Medical, Inc.
- Decision
- Unknown
- Date received
- 2016-12-09
- Decision date
- 2017-02-03
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.