Atlas FDA

PRESSURE INJECTABLE PICC

FDA 510(k) clearance K073451 · decided 2008-01-15

Clearance details

K-number
K073451
Device name
PRESSURE INJECTABLE PICC
Applicant
Arrow International, Inc.
Decision
Substantially Equivalent
Date received
2007-12-10
Decision date
2008-01-15
Days to decision
36 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
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravas recall (Z-2590-2023)ARROW INTERNATIONAL Inc.2023-09-15
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-te recall (Z-0127-2016)Arrow International Inc2015-10-15
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Cathete recall (Z-2489-2015)Arrow International Inc2015-08-31
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasoun recall (Z-2462-2015)Arrow International Inc2015-08-25
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflu recall (Z-0066-2015)Arrow International Inc2014-10-14
Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451- recall (Z-1682-2010)Arrow International Inc2010-05-26