510(k) K160925 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
VPS Rhythm Device with TipTracker Technology
| Applicant | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Dec 22, 2016 |
| Received | Apr 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2023 | ARROW INTERNATIONAL Inc. Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than Open, Classified |
LJS | None listed |
| May 17, 2018 | Arrow International Inc VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ
Product Usage:
To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave c Terminated |
LJS | None listed |
| May 17, 2018 | Arrow International Inc VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO
Product Usage:
To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip ap Terminated |
LJS | None listed |
| May 17, 2018 | Arrow International Inc VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP
Product Usage:
To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip Terminated |
LJS | None listed |
| Apr 11, 2018 | Arrow International Inc VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ Terminated |
LJS | None listed |
| Apr 11, 2018 | Arrow International Inc VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO Terminated |
LJS | None listed |
| Apr 11, 2018 | Arrow International Inc VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.