Atlas FDA

ARROW PRESSURE INJECTABLE PICC

FDA 510(k) clearance K061289 · decided 2006-08-24

Clearance details

K-number
K061289
Device name
ARROW PRESSURE INJECTABLE PICC
Applicant
Arrow International, Inc.
Decision
Substantially Equivalent
Date received
2006-05-09
Decision date
2006-08-24
Days to decision
107 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

RecordFirmDate
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-te recall (Z-0127-2016)Arrow International Inc2015-10-15
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasoun recall (Z-2462-2015)Arrow International Inc2015-08-25
Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451- recall (Z-1682-2010)Arrow International Inc2010-05-26