510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

C-Port Distal Anastomosis System

K053524510(k) TraditionalCleared Nov 16, 2006332-day reviewClass II21 CFR 878.4300Recalls 1

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 16, 2006 as substantially equivalent to K040832 (Cardica, Inc., 2005) after a 332-day review. Its family tree reaches back 10 generations to 1993. 6 later devices descend from it. It has been recalled once.

Decided
Nov 16, 2006
Review
332 days
Class
Class II
Product code
FZP
Recalls
1
Predicates
1

Its longest line of descent runs back 10 generations to K933887 (1993). 33 ancestors in all, the oldest K771412 (1977). 6 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 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) K040832 · C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050 · Cardica, Inc. · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 13 other ancestors4 generations back: 8 other ancestors5 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K040832 · C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050 · Cardica, Inc. · 2005K031623 · 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 · 1993−10−50
  1. Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 6 generations between
  3. 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  4. 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  5. 1 generation backK040832 C-Port Anastomosis System (Deployment System, Clip, Accessories)…Cardica, Inc. · 2005
  6. This deviceK053524 C-Port Distal Anastomosis SystemCardica, Inc. · 2006
  7. Descendant · cites it directly · 5 of its ownK063644 Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2007 · Recalled
  8. Descendant · 2 generations on · 1 of its ownK090872 Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 2009 · Recalled
  9. Descendant · cites it directly · 1 of its ownK070548 C-Port Flexa Distal Anastomosis SystemCardica, Inc. · 2007 · Recalled
  10. Descendant · 3 generations on · 0 of its ownK101018 Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc. · 2010 · Recalled
  11. Descendant · 2 generations on · 0 of its ownK073304 Cardica C-Port X-Change Anastomosis System and Handle and XA…Cardica, Inc. · 2007
Show all 10 generations
  1. Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 9 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
  3. 8 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
  4. 7 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
  5. 6 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
  6. 5 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  7. 4 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  8. 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  9. 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  10. 1 generation backK040832 C-Port Anastomosis System (Deployment System, Clip, Accessories)…Cardica, Inc. · 2005
  11. This deviceK053524 C-Port Distal Anastomosis SystemCardica, Inc. · 2006

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

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

Most influential descendants

Showing 5 of 6 · See all
  • 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 · cites it directly1descendant
  • K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc. · 2010 · 3 generations on0descendants
  • K073304Cardica C-Port X-Change Anastomosis System and Handle and XA X-Change SubassembliesCardica, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K933887Implantable ClipUnited States Surgical, A Division of Tyco Healthc1993—
−9K962043Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc19967
−8K994160Coalescent Surgical Sutured-ClipCoalescent Surgical2000—
−7K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
−6K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
−5K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
−4K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical2002—
−3K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20031
−2K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20034
−1K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model…Cardica, Inc.2005—
0 (this device)K053524C-Port Distal Anastomosis SystemCardica, Inc.2006—
+1K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.20071
+2K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.20091
+1K070548C-Port Flexa Distal Anastomosis SystemCardica, Inc.20071
+3K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc.20101
+2K073304Cardica C-Port X-Change Anastomosis System and Handle and XA X-Change…Cardica, Inc.2007—

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
200740
200910
201010
FIG. 1 — Lineage of K053524, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050
Summary page 1
…stomosis System Common Name: Cardiovascular Surgical Instruments Predicate Device(s) Cardica® C-Port® Anastomosis System (K040832) Device Description The Cardica® C-Port® Anastomosis System is a sterile, single use device for…
Cardica, Inc.2005—

Also cleared against K040832: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.20075
K070548C-Port Flexa Distal Anastomosis SystemCardica, Inc.20071

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 2, 2018Class IIZ-2433-2018Under Investigation by firmFollowing 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 13 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
  • 6 of the 33 ancestors have a recall of any class.
  • Of its descendants, K063644 (Cardica, Inc., 2007) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K040832.

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~Port® xA 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 K040832

1 other device cites the same predicate.

  • K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc. · 20071 recall

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/K053524 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053524: C-Port Distal Anastomosis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053524

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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