510(k) K073451 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PRESSURE INJECTABLE PICC
| Applicant | Arrow International, Inc., Reading PA, US |
| Decision | Substantially Equivalent, Jan 15, 2008 |
| Received | Dec 10, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2023 | ARROW INTERNATIONAL Inc. Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular Open, Classified |
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 31, 2015 | Arrow International Inc Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days Terminated |
OBJ | 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 |
| Oct 14, 2014 | Arrow International Inc Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe. Terminated |
DQY | 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.