Atlas FDA

PICC

FDA 510(k) clearance K042126 · decided 2004-08-27

Clearance details

K-number
K042126
Device name
PICC
Applicant
Arrow Intl., Inc.
Decision
Unknown
Date received
2004-08-06
Decision date
2004-08-27
Days to decision
21 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 Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes recall (Z-2825-2015)Arrow International Inc2015-09-30
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasoun recall (Z-2462-2015)Arrow International Inc2015-08-25
Arrow Peripherally Inserted Central Catheter recall (Z-1503-2009)Arrow International Inc2009-06-24