510(k) K061289 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
ARROW PRESSURE INJECTABLE PICC
| Applicant | Arrow International, Inc., Reading PA, US |
| Decision | Substantially Equivalent, Aug 24, 2006 |
| Received | May 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061289
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2019 | Arrow International Inc Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm
EU-05052-HPMSB Terminated |
LJS | None listed |
| Apr 11, 2018 | Arrow International Inc PICC Catheter Trimmer ; Product Code:PC-00001-T Terminated |
LJS | None listed |
| Dec 22, 2017 | Arrow International Inc Arrow Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB Terminated |
LJS | None listed |
| May 9, 2017 | Arrow 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 |
LJS | None listed |
| Feb 17, 2016 | Arrow International Inc Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days.
An access kit only, contains no base components Terminated |
LJS | None listed |
| Feb 17, 2016 | Arrow International Inc Cather, Ultrasound, Intravascular
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. Terminated |
LJS | None listed |
| Feb 17, 2016 | Arrow International Inc Catheter, Percutaneous
The Arrow Single-Lumen Catheter permits venous access to the central circulation. Terminated |
LJS | None listed |
| Feb 17, 2016 | Arrow 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 |
LJS | None listed |
| Oct 15, 2015 | Arrow International Inc 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days. Terminated |
LJS | None listed |
| Aug 25, 2015 | Arrow International Inc PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound
Product Usage:
catheter, intravascular, therapeutic, ultrasound Terminated |
LJS | None listed |
| May 26, 2010 | Arrow 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 |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.