Atlas FDA

ARROW PICC POWERED BY ARROW VPS STYLET

FDA 510(k) clearance K121941 · decided 2012-09-07

Clearance details

K-number
K121941
Device name
ARROW PICC POWERED BY ARROW VPS STYLET
Applicant
Arrow International (Subsidiary of Teleflex Inc.)
Decision
Substantially Equivalent
Date received
2012-07-02
Decision date
2012-09-07
Days to decision
67 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 Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF C recall (Z-2591-2023)ARROW INTERNATIONAL Inc.2023-09-15
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantag recall (Z-0207-2016)Arrow International Inc2015-11-04
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), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterizati recall (Z-1030-2015)Arrow International Inc2015-01-29
Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, recall (Z-1494-2014)Arrow International Inc2014-04-24