Atlas FDA

BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE

FDA 510(k) clearance K092318 · decided 2009-10-30

Clearance details

K-number
K092318
Device name
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2009-08-04
Decision date
2009-10-30
Days to decision
87 days
Clearance type
Traditional
Product code
LHI
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mcgaw Park, IL, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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