510(k) K060309 ยท DSP System, Balloon, Intra-Aortic And Control
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
| Applicant | Arrow Intl., Inc., Everett MA, US |
| Decision | Substantially Equivalent, Apr 6, 2006 |
| Received | Feb 7, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060309
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump Open, Classified |
DSP | None listed |
| Dec 15, 2022 | ARROW INTERNATIONAL Inc. Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump Open, Classified |
DSP | None listed |
| Jun 26, 2020 | Arrow International Inc Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 Terminated |
DSP | None listed |
| Jun 26, 2020 | Arrow International Inc Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E Terminated |
DSP | None listed |
| Jun 26, 2020 | Arrow International Inc Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 Terminated |
DSP | None listed |
| Jun 26, 2020 | Arrow International Inc Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E Terminated |
DSP | None listed |
| Jun 26, 2020 | Arrow International Inc Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I Terminated |
DSP | None listed |
| Jun 26, 2020 | Arrow International Inc Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J Terminated |
DSP | None listed |
| Jun 26, 2020 | Arrow International Inc Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL Terminated |
DSP | None listed |
| Jun 26, 2020 | Arrow International Inc Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535 Terminated |
DSP | None listed |
| Jan 25, 2008 | Arrow International Inc AutoCAT 2 Series Intra-Aortic Balloon Pumps
Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149 Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.