Atlas FDA

CG+ ARROW PICC POWERED BY ARROW VPS STYLET

FDA 510(k) clearance K122545 · decided 2012-09-20

Clearance details

K-number
K122545
Device name
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
Applicant
Arrow International (Subsidiary of Teleflex Inc.)
Decision
Substantially Equivalent
Date received
2012-08-21
Decision date
2012-09-20
Days to decision
30 days
Clearance type
Special
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Reading, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterizati recall (Z-1030-2015)Arrow International Inc2015-01-29