510(k) K011056 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Oct 24, 2001 |
| Received | Apr 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C,
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Terminated |
QEW | None listed |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS
The Arrow-Trerotola Percutaneous Thrombolytic Dev Terminated |
QEW | None listed |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun Terminated |
QEW | None listed |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS
The Arrow-Trerotola Percutaneous Thrombolytic Devic Terminated |
QEW | None listed |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunctio Terminated |
QEW | None listed |
| Feb 15, 2022 | TELEFLEX MEDICAL INC 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative)
Terminated |
QEW | None listed |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit)
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotato Terminated |
QEW | None listed |
| Nov 18, 2021 | Arrow International Inc Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR
Product Code: PT-12709-WC
The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Terminated |
DXE | None listed |
| Nov 18, 2021 | Arrow International Inc Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR
Product Code: PT-65709-HFWC
The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with th Terminated |
DXE | None listed |
| Nov 18, 2021 | Arrow International Inc Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR
Product Code: PT-65709-W
The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the A Terminated |
DXE | None listed |
| Nov 18, 2021 | Arrow International Inc Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR
Product Code: PT-65709-WC
The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Terminated |
DXE | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts Terminated |
DXE | None listed |
| May 13, 2005 | Arrow International Inc The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached t Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.