Atlas FDA

ARRW EVOLUTION

FDA 510(k) clearance K112896 · decided 2012-05-10

Clearance details

K-number
K112896
Device name
ARRW EVOLUTION
Applicant
Arrow International (Subsidiary of Teleflex Inc.)
Decision
Substantially Equivalent
Date received
2011-09-30
Decision date
2012-05-10
Days to decision
223 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 EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogen recall (Z-2698-2017)Arrow International Inc2017-06-27
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peri recall (Z-1705-2017)Arrow International Inc2017-03-08
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantag recall (Z-0207-2016)Arrow International Inc2015-11-04