510(k) K132713 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
NMI COAXIAL MICROINTRODUCER SET
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Sep 27, 2013 |
| Received | Aug 30, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132713
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-749 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-750 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-751 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-752 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-754 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG
Catalog Number: 45-756 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-758 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-759 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-762 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-765 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-767 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-774 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-775 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system.
Catalog Number: 45-776 Open, Classified |
DRE | None listed |
| Mar 21, 2024 | Angiodynamics, Inc. MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. -
Catalog Number: 45-781 Open, Classified |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.