C-Port Distal Anastomosis System
FDA 510(k) K053524 · Cardica, Inc.
510(k) numberK053524
Submission
- Device name
- C-Port Distal Anastomosis System
- Applicant
- Cardica, Inc.
Redwood City, CA, US - Received
- December 19, 2005
- Decision date
- November 16, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FZP – Clip, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K254231 | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating ClipsFZP · Traditional | Taiwan Surgical Corporation | 07/20/2026SE |
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| K253781 | InnoClip Clip ApplierFZP · Special | Taiwan Surgical Corporation | 12/22/2025SE |
| K250643 | Disposable Polymer Ligation ClipsFZP · Traditional | Hangzhou Kangji Medical Instrument Co., Ltd. | 11/20/2025SE |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional | Teleflex Medical | 07/03/2025SE |
| K242541 | Gem ZipclipFZP · Traditional | Synovis Micro Companies Alliance A Subsidiary of… | 01/15/2025SE |
| K221495 | SOLID CLIP Single Use Clip ApplierFZP · Traditional | Medscope Biotech Co., Ltd. | 07/18/2024SE |
| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | Teleflex Medical | 01/12/2024SE |
| K230966 | angiOCCLUDE Ligating ClipsFZP · Traditional | A2 Medical Systems, LLC | 09/19/2023SE |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special | Ethicon Endo Surgery, LLC | 08/29/2023SE |
More from Ethicon Endo Surgery, LLC
| 510(k) | Device | Decision |
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| K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadGDW · Traditional | 07/20/2016SE |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter…GDW · Traditional | 01/15/2016SE |
| K140118 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeGDW · Special | 02/25/2014SE |
| K140170 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeGDW · Special | 02/19/2014SE |
| K132581 | Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…GDW · Traditional | 01/07/2014SE |
| K101018 | Cardica C-Port Xa Plus Distal Anastomosis System, Model FG-000100FZP · Special | 06/25/2010SE |
| K091017 | Cardica Pas-Port Proximal Anastomosis System, Model FG-000001FZP · Special | 04/29/2009SE |
| K090872 | Modification to Cardica C-Port Xa Distal Anastomosis SystemFZP · Special | 04/21/2009SE |
| K081225 | Cardica Pas-Port Proximal Anastomosis SystemFZP · Traditional | 09/05/2008SE |
| K073304 | Cardica C-Port X-Change Anastomosis System and Handle and Xa X-Change SubassembliesFZP · Special | 12/20/2007SE |
Questions and answers
When was C-Port Distal Anastomosis System cleared by the FDA?
C-Port Distal Anastomosis System (K053524) received a 510(k) decision of Substantially Equivalent on November 16, 2006, 332 days after the submission was received.
What is the product code of K053524?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.