Atlas FDA

CG+ ARROW PICC POWERED BY ARROW VPS STYLET

FDA 510(k) clearance K130876 · decided 2013-04-26

Clearance details

K-number
K130876
Device name
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
Applicant
Arrow International, Inc.
Decision
Substantially Equivalent
Date received
2013-03-29
Decision date
2013-04-26
Days to decision
28 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

RecordFirmDate
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 International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Cathete recall (Z-2489-2015)Arrow International Inc2015-08-31