ClearanceBrief
510(k) K061289 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

ARROW PRESSURE INJECTABLE PICC

ApplicantArrow International, Inc., Reading PA, US
DecisionSubstantially Equivalent, Aug 24, 2006
ReceivedMay 9, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K061289

DateFirm and productCodeLinked 510(k)
Dec 20, 2019Arrow International Inc
Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB
Terminated
LJSNone listed
Apr 11, 2018Arrow International Inc
PICC Catheter Trimmer ; Product Code:PC-00001-T
Terminated
LJSNone listed
Dec 22, 2017Arrow International Inc
Arrow Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
Terminated
LJSNone listed
May 9, 2017Arrow International Inc
Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access t
Terminated
LJSNone listed
Feb 17, 2016Arrow International Inc
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Terminated
LJSNone listed
Feb 17, 2016Arrow International Inc
Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Terminated
LJSNone listed
Feb 17, 2016Arrow International Inc
Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
Terminated
LJSNone listed
Feb 17, 2016Arrow International Inc
Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring
Terminated
LJSNone listed
Oct 15, 2015Arrow International Inc
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Terminated
LJSNone listed
Aug 25, 2015Arrow International Inc
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
Terminated
LJSNone listed
May 26, 2010Arrow International Inc
Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW;
Terminated
LJSNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.