510(k) · Cleared
Recalled · Class II · 2018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardica, Inc. · FZP Clip, Implantable
Cleared on Jun 25, 2010 as substantially equivalent to K090872 (Cardica, Inc., 2009) after a 73-day review. Its family tree reaches back 13 generations to 1993. It has been recalled once.
- Decided
- Jun 25, 2010
- Review
- 73 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 13 generations to K933887 (1993). 36 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.
- Root · 13 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 9 generations between
- 3 generations backK053524 C-Port Distal Anastomosis SystemCardica, Inc. · 2006 · Recalled
- 2 generations backK063644 Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2007 · Recalled
- 1 generation backK090872 Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2009 · Recalled
- This deviceK101018 Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc. · 2010
Show all 13 generations
- Root · 13 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 12 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 11 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 10 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 9 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 8 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 7 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 6 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 5 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 4 generations backK040832 C-Port Anastomosis System (Deployment System, Clip, Accessories)…Cardica, Inc. · 2005
- 3 generations backK053524 C-Port Distal Anastomosis SystemCardica, Inc. · 2006 · Recalled
- 2 generations backK063644 Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2007 · Recalled
- 1 generation backK090872 Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2009 · Recalled
- This deviceK101018 Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −12 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −11 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −10 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −9 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −8 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −7 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −6 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −5 | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 4 |
| −4 | K040832 | C-Port Anastomosis System (Deployment System, Clip, Accessories), Model… | Cardica, Inc. | 2005 | — |
| −3 | K053524 | C-Port Distal Anastomosis System | Cardica, Inc. | 2006 | 1 |
| −2 | K063644 | Cardica C-Port XA Distal Anastomosis System | Cardica, Inc. | 2007 | 1 |
| −1 | K090872 | Modification to Cardica C-Port XA Distal Anastomosis System | Cardica, Inc. | 2009 | 1 |
| 0 (this device) | K101018 | Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100 | Cardica, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FZP device
- #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090872 | Modification to Cardica C-Port XA Distal Anastomosis SystemSummary page 1…Cardiovascular Surgical Instruments Legally Marketed Predicate Device(s) Cardica® C-Port® xA PLUS Distal Anastomosis System (K090872) April 21, 2009 CARDICA, INC. CONFIDENTIAL & PROPRIETARY Pg. 1of 6 F.… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2018 | Class II | Z-2433-2018 | Under Investigation by firm | Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 9 of the 36 ancestors have a recall of any class.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 2025
MAUDE reports naming product code FZP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 31 | 1 | 1,877 |
| 2008 | 4 | 23 | 6 | 981 |
| 2009 | 3 | 22 | 0 | 2,160 |
| 2010 | 6 | 47 | 1 | 2,367 |
| 2011 | 3 | 124 | 0 | 1,678 |
| 2012 | 2 | — | 1 | 1,677 |
| 2013 | 3 | 47 | 0 | 2,381 |
| 2014 | 3 | 29 | 1 | 2,320 |
| 2015 | 8 | 182 | 0 | 2,871 |
| 2016 | 5 | 72 | 2 | 1,840 |
| 2017 | 4 | 29 | 1 | 2,594 |
| 2018 | 4 | 143 | 0 | 2,718 |
| 2019 | 1 | — | 3 | 2,903 |
| 2020 | 2 | — | 1 | 1,760 |
| 2021 | 0 | — | 0 | 1,759 |
| 2022 | 3 | 227 | 0 | 1,575 |
| 2023 | 3 | 65 | 0 | 1,918 |
| 2024 | 2 | — | 0 | 2,067 |
| 2025 | 5 | 90 | 0 | 1,902 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Cardica® C-Port® xA Plus Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101018: Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101018
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026