510(k) Report

510(k) · Cleared

Cleared

C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050

K040832510(k) TraditionalCleared Nov 10, 2005589-day reviewClass II21 CFR 878.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardica, Inc. · FZP Clip, Implantable

Cleared on Nov 10, 2005 as substantially equivalent to K962043 (United States Surgical, A Division of Tyco Healthc, 1996) and 3 other predicates after a 589-day review. Its family tree reaches back 9 generations to 1993. 7 later devices descend from it.

Decided
Nov 10, 2005
Review
589 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
4

Its longest line of descent runs back 9 generations to K933887 (1993). 32 ancestors in all, the oldest K771412 (1977). 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 2 other ancestors1998: 2 other ancestors1997: 3 other ancestors1996: 2 other ancestors1994: 3 other ancestors1991: 1 other ancestor1989: 1 other ancestor1984: 1 other ancestor1982: 1 other ancestor1977: 1 other ancestor2001: 1 other ancestor1995: 3 other ancestors1992: 1 other ancestor2007: 4 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant clearedK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 1993K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000×6: 6 generations cleared close together, K012317 (2001), K013664 (2002), K021407 (2002), K023125 (2002), K024366 (2003), K031623 (2003) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 13 other ancestors3 generations back: 8 other ancestors4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K031623 · Modification to Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalledK024366 · Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalledK023125 · Coalescent U-Clip- and Accessories · Coalescent Surgical · 2002K021407 · Coalescent Surgical U-Clip - or Other TBD and Accessories · Coalescent Surgical · 2002K013664 · Coalescent Surgical U-Clip · Coalescent Surgical · 2002K012317 · Coalescent Surgical U-Clip · Coalescent Surgical · 2001K994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 1993−50
  1. Root · 9 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 5 generations between
  3. 3 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  4. 2 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  5. 1 generation backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  6. This deviceK040832 C-Port Anastomosis System (Deployment System, Clip, Accessories)…Cardica, Inc. · 2005
  7. Descendant · cites it directly · 6 of its ownK053524 C-Port Distal Anastomosis SystemCardica, Inc. · 2006 · Recalled
  8. Descendant · cites it directly · 5 of its ownK063644 Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2007 · Recalled
  9. Descendant · 2 generations on · 1 of its ownK090872 Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2009 · Recalled
  10. Descendant · 2 generations on · 1 of its ownK070548 C-Port Flexa Distal Anastomosis SystemCardica, Inc. · 2007 · Recalled
  11. Descendant · 3 generations on · 0 of its ownK101018 Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc. · 2010 · Recalled
Show all 9 generations
  1. Root · 9 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 8 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
  3. 7 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
  4. 6 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
  5. 5 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
  6. 4 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  7. 3 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  8. 2 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  9. 1 generation backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  10. This deviceK040832 C-Port Anastomosis System (Deployment System, Clip, Accessories)…Cardica, Inc. · 2005

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 12007: 42009: 12010: 1
2006high 4 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K053524C-Port Distal Anastomosis SystemCardica, Inc. · 2006 · cites it directly6descendants
  • K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2007 · cites it directly5descendants
  • K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2009 · 2 generations on1descendant
  • K070548C-Port Flexa Distal Anastomosis SystemCardica, Inc. · 2007 · 2 generations on1descendant
  • K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K933887Implantable ClipUnited States Surgical, A Division of Tyco Healthc1993—
−8K962043Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc19967
−7K994160Coalescent Surgical Sutured-ClipCoalescent Surgical2000—
−6K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
−5K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
−4K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
−3K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical2002—
−2K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20031
−1K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20034
0 (this device)K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model…Cardica, Inc.2005—
+1K053524C-Port Distal Anastomosis SystemCardica, Inc.20061
+1K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.20071
+2K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.20091
+2K070548C-Port Flexa Distal Anastomosis SystemCardica, Inc.20071
+3K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc.20101

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
198210
198410
198910
199110
199210
199430
199530
199620
199730
199820
200020
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200740
200910
201010
FIG. 1 — Lineage of K040832, 1993–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K962043Auto Suture Modified VCS Clip Applier
Summary page 1
…tantial Equivalence The C-PortTM Anastomosis System is substantially equivalent to US Surgical Corporation's Auto SutureTM Modified VCSTM ClipTM Applier (K962043, 21 CFR 878.4800 and the Ethicon ENDOPATHTM and PROXIMATETM Linear Cutters and Staplers (K020779, 21 CFR 878.4750…
United States Surgical, A Division of Tyco Healthc19967
*K020779Proximate and Endopath Linear Cutters and Staplers
Summary page 1
…rporation's Auto SutureTM Modified VCSTM ClipTM Applier (K962043, 21 CFR 878.4800 and the Ethicon ENDOPATHTM and PROXIMATETM Linear Cutters and Staplers (K020779, 21 CFR 878.4750), and the Coalescent Surgical U-ClipTM (K031623, K994160, 21 CFR 870.4300). The subject devic…
Ethicon Endo-Surgery, Inc.200217
*K031623Modification to Coalescent Surgical U-Clip and Accessories
Summary page 1
…878.4800 and the Ethicon ENDOPATHTM and PROXIMATETM Linear Cutters and Staplers (K020779, 21 CFR 878.4750), and the Coalescent Surgical U-ClipTM (K031623, K994160, 21 CFR 870.4300). The subject device is substantially equivalent to the predicate devices with regar…
Coalescent Surgical20034
*K994160Coalescent Surgical Sutured-Clip
Summary page 1
…78.4800 and the Ethicon ENDOPATHTM and PROXIMATETM Linear Cutters and Staplers (K020779, 21 CFR 878.4750), and the Coalescent Surgical U-ClipTM (K031623, K994160, 21 CFR 870.4300). The subject device is substantially equivalent to the predicate devices with regard to indi…
Coalescent Surgical2000—

Also cleared against K962043: 3 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053524C-Port Distal Anastomosis SystemCardica, Inc.20066
K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.20075

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6 months on median.
  • 6 of the 32 ancestors have a recall of any class.
  • Of its descendants, K053524 (Cardica, Inc., 2006) has gone furthest, with 6 descendants of its own.
  • 3 other devices also cite its predicate K962043.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZP

5in 2025

2007: 62008: 42009: 32010: 62011: 32012: 22013: 32014: 32015: 82016: 52017: 42018: 42019: 12020: 22022: 32023: 32024: 22025: 52026 (partial year): 2
2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007: 31 days median2008: 23 days median2009: 22 days median2010: 47 days median2011: 124 days median2013: 47 days median2014: 29 days median2015: 182 days median2016: 72 days median2017: 29 days median2018: 143 days median2022: 227 days median2023: 65 days median2025: 90 days median
2007high 227 (2022) · low 22 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FZP

1in 2020

2007: 12008: 62010: 12012: 12014: 12016: 22017: 12019: 32020: 1
2007high 6 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FZP

1,902in 2025

2007: 1,8772008: 9812009: 2,1602010: 2,3672011: 1,6782012: 1,6772013: 2,3812014: 2,3202015: 2,8712016: 1,8402017: 2,5942018: 2,7182019: 2,9032020: 1,7602021: 1,7592022: 1,5752023: 1,9182024: 2,0672025: 1,902
2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200763111,877
20084236981
200932202,160
201064712,367
2011312401,678
20122—11,677
201334702,381
201432912,320
2015818202,871
201657221,840
201742912,594
2018414302,718
20191—32,903
20202—11,760
20210—01,759
2022322701,575
202336501,918
20242—02,067
202559001,902
20262—0—

What is it indicated for?

The Cardica® C-PortTM 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.

Also cleared against K962043

3 other devices cite the same predicate.

  • K213813DuraFuse Clip and Applier SystemNeuramedica, Inc. · 2022
  • K173323AnastoClip GC Closure SystemLeMaitre Vascular, Inc. · 20181 recall
  • K994160Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000

More from Cardica, Inc.

15 FDA decisions under this applicant name. See the company

  • K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc. · 2016
  • K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White CartridgeCardica, Inc. · 2016
  • K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc. · 20142 recalls
  • K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc. · 20142 recalls
  • K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple CartridgeCardica, Inc. · 20141 recall

Recent decisions in FZP

The FZP category page

  • K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
  • K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026
  • K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
  • K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025

https://510kreport.com/device/K040832 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040832: C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040832

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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