| Primary Device ID | M729500580C2 |
| NIH Device Record Key | b135dfbe-1045-42f5-be12-3a6cc28aa018 |
| Commercial Distribution Discontinuation | 2025-02-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Cardiva Catalyst II VCS |
| Version Model Number | 500-580C |
| Company DUNS | 128112195 |
| Company Name | CARDIVA MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| M729500580C2 - Cardiva Catalyst II VCS | 2025-03-04The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst II is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths. |
| M729500580C2 - Cardiva Catalyst II VCS | 2025-03-04 The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiv |
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| M729700500DX1 - Cardiva VASCADE 5F VCS | 2021-02-05 The VASCADE VCS is intended to seal the femoral arterial access site at the completion of an endovascular procedure. The system |
| M729700580I1 - Cardiva VASCADE 6/7F VCS | 2021-02-05 The VASCADE VCS is intended to seal the femoral arterial access site at the completion of an endovascular procedure. The system |
| M729800612C2 - Cardiva VASCADE MVP VVCS 6-12F | 2021-02-05 The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal the femoral venous access site at the completion of ca |