Atlas FDA

ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS

FDA 510(k) clearance K113277 · decided 2012-06-21

Clearance details

K-number
K113277
Device name
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
Applicant
Arrow International, Inc.
Decision
Substantially Equivalent
Date received
2011-11-07
Decision date
2012-06-21
Days to decision
227 days
Clearance type
Traditional
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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Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 C recall (Z-2378-2026)ARROW INTERNATIONAL, LLC2026-06-13
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantag recall (Z-0207-2016)Arrow International Inc2015-11-04