510(k) K051655 ยท DQR Cannula, Catheter
ANGIODYNAMICS, INC., MICRO ACCESS KITS
| Applicant | AngioDynamics, Inc., Queensburgy NY, US |
| Decision | Substantially Equivalent, Sep 12, 2005 |
| Received | Jun 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2020 | Angiodynamics, Inc. Angiodynamics 5F Standard Micro-Introducer Kit - indicated for
percutaneous introduction of a guidewire or catheter into
the vascular system, Catalog Number: 06597035
UPN: H787065970355 Terminated |
DQR | None listed |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Terminated |
DYB | None listed |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened M Terminated |
DYB | None listed |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened M Terminated |
DYB | None listed |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Terminated |
DYB | None listed |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffen Terminated |
DYB | None listed |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stif Terminated |
DYB | None listed |
| Sep 28, 2016 | Angiodynamics, Inc. ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103
Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a sm Terminated |
DYB | None listed |
| May 25, 2013 | Angiodynamics, Inc. AngioDynamics Micro Introducer Kits under the following labeling:
1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer K Terminated |
DQR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.