Company
Angiodynamics Inc. (Navilyst Medical Inc.)
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
78recalls (0 in 12 months)
76recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 54 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 7 |
| NEY | System, Ablation, Microwave And Accessories | 5 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 2 |
| DYB | Introducer, Catheter | 2 |
| FPA | Set, Administration, Intravascular | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| LJW | Tracheotome | 1 |
| N/A | 1 | |
| OEQ | Angiography/Angioplasty Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2021 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer
Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters. Terminated |
DYB | K122084 |
| Feb 22, 2021 | Angiodynamics Inc. (Navilyst Medical Inc.) Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutrition Terminated |
LJT | K062414 |
| Oct 2, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151 Terminated |
GEI | K010060 |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to h Terminated |
LJT | K122767 |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 Terminated |
LJT | K122767 |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hy Terminated |
LJT | K122767 |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to Terminated |
LJT | K122767 |
| Sep 18, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hy Terminated |
LJT | K122767 |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
(1)Solero Applicator 29cm PG
Catalog Number:700106003
UPN: H7877001060030
(2)Solero Applicator 29cm PG US
Catalog Number:700106003US
UPN Terminated |
NEY | K162449 |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
(1)Solero Applicator 19cm PG
Catalog Number: 700106002
UPN: H7877001060020
(2)Solero Applicator 19cm PG US
Catalog Number:700106002US
U Terminated |
NEY | K162449 |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
(1) Solero Applicator 14cm PG
Catalog Number: 700106001
UPN:H7877001060010;
(2)Solero Applicator 14cm PG US
Catalog Number:700106001US
Terminated |
NEY | K162449 |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
(1) Solero Generator Refurbished PG
Catalog Number: 12740000D UPN: H78712740000D0
(2) Solero Generator Refurbished US PG
Catalog Number: Terminated |
NEY | K162449 |
| Apr 17, 2019 | Angiodynamics Inc. (Navilyst Medical Inc.) AngioDynamics Solero Microwave Tissue Ablation (MTA) System:
Solero Generator PG
(1) Catalog Number:12740000
UPN: H78712740000
(2) Solero Generator US PG
Catalog Number: 12740000US
UPN: H787127400 Terminated |
NEY | K162449 |
| Oct 16, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL
SYSTEM (LTP) PG) Cat. no. 60M183481 Terminated |
LJS | K121990 |
| Oct 16, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711 Terminated |
LJS | K091261 |
| Jul 24, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021
Box of 1 Port - Product Usage - Long-term access to the Terminated |
LJT | K131694 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL XCELA PICC, Catalog Number 60M122272 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038 Terminated |
LJS | K163452 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033 Terminated |
LJS | K163452 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032 Terminated |
LJS | K163452 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019 Terminated |
LJS | K163452 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) CAN 5F DUAL XCELA PICC, Catalog Number 60M701532 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936 Terminated |
LJS | K163452 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097 Terminated |
LJS | K121990 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M183481 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL XPP KIT, Catalog Number 60M183104 Terminated |
LJS | K121990 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582 Terminated |
LJS | K152409 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M181578 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) 5F DL BIOFLO PICC, Catalog Number 60M180592 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M161567 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M150373 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) 5F DL BIOFLO PASV, Catalog Number 60M141006 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PASV, Catalog Number 60M132324 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL BIOFLO PICC, Catalog Number 60M071831 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472 Terminated |
FOZ | K161866 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS 5F DL XPP, Catalog Number 60M030393 Terminated |
LJS | K121990 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) RS TANDEM 5F DL XPP, Catalog Number 60M019881 Terminated |
LJS | K121990 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810 Terminated |
FOZ | K161866 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490 Terminated |
FOZ | K161866 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 Terminated |
DYB | K000313 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892 Terminated |
LJS | K150448 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886 Terminated |
LJS | K142616 |
| May 10, 2018 | Angiodynamics Inc. (Navilyst Medical Inc.) Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882 Terminated |
LJS | K150448 |
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