510(k) K090300 ยท MEB Pump, Infusion, Elastomeric
MODIFICATION TO AUTOFUSER
| Applicant | Ace Medical Us, LLC, Powell OH, US |
| Decision | Substantially Equivalent, Apr 30, 2009 |
| Received | Feb 6, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
| Oct 2, 2018 | Arrow International Inc AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump Terminated |
MEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.