510(k) Report

510(k) · Cleared

Cleared

Symmetry Aortic Clip System

K003446510(k) TraditionalCleared May 21, 2001196-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

St. Jude Medical Cardiovascular Group, Inc. · NCA Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

Cleared on May 21, 2001 as substantially equivalent to K970793 (United States Surgical, A Division of Tyco Healthc, 1997) after a 196-day review. Its family tree reaches back 1 generation to 1997. 49 later devices descend from it.

Decided
May 21, 2001
Review
196 days
Class
Class II
Product code
NCA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K970793 (1997). 49 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2006: 5 descendants cleared2002: 3 descendants cleared2005: 3 descendants cleared2004: 4 descendants cleared2003: 2 descendants cleared2009: 2 descendants cleared2010: 2 descendants cleared2020: 1 descendant cleared2007: 4 descendants cleared2015: 1 descendant cleared2017: 3 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2025: 1 descendant cleared2011: 1 descendant cleared2016: 2 descendants cleared2026: 3 descendants cleared2018: 2 descendants cleared2019: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant clearedK970793 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 10 descendants3 generations forward: 4 descendants4 generations forward: 10 descendants5 generations forward: 9 descendants6 generations forward: 4 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 1 descendant10 generations forward: 1 descendant11 generations forward: 3 descendants12 generations forward: 2 descendants K970793 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 19970+5+10
  1. Root · 1 generation backK970793 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1997
  2. This deviceK003446 Symmetry Aortic Clip SystemSt. Jude Medical Cardiovascular Group, Inc. · 2001
  3. Descendant · cites it directly · 44 of its ownK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
  4. Descendant · 2 generations on · 43 of its ownK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  5. Descendant · 2 generations on · 42 of its ownK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  6. Descendant · 2 generations on · 41 of its ownK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  7. Descendant · 2 generations on · 32 of its ownK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2002: 32003: 22004: 42005: 32006: 52007: 42008: 22009: 22010: 22011: 12012: 12013: 12014: 12015: 12016: 22017: 32018: 22019: 12020: 12021: 12022: 12023: 22025: 12026: 3
2002high 5 (2006) · low 0 (2024)2026

Most influential descendants

Showing 5 of 49 · See all
  • K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002 · cites it directly44descendants
  • K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002 · 2 generations on43descendants
  • K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002 · 2 generations on42descendants
  • K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · 2 generations on41descendants
  • K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · 2 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K970793Implantable ClipUnited States Surgical, A Division of Tyco Healthc1997—
0 (this device)K003446Symmetry Aortic Clip SystemSt. Jude Medical Cardiovascular Group, Inc.2001—
+1K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
+2K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
+2K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical2002—
+2K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20031
+2K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20034

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200320
200440
200530
200650
200740
200820
200920
201020
201110
201210
201310
201410
201510
201620
201730
201820
201910
202010
202110
202210
202320
202510
202630
FIG. 1 — Lineage of K003446, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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
*K970793Implantable Clip
Summary page 1
…ally Marketed Predicate Devices The Aortic Connector System is substantially equivalent to the U.S. Surgical AutoSuture Vascular Anastomosis Clip Cartridge and Applier (K970793). B. Device Description The Aortic Connector System is a mechanical device used to facilitate an aortic vein graft anastomosis.…
United States Surgical, A Division of Tyco Healthc1997—

Also cleared against K970793: 4 other devices →

What descends from it? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K013664Coalescent Surgical U-ClipCoalescent Surgical200244
K081225Cardica Pas-Port Proximal Anastomosis SystemCardica, Inc.20082
K061626Vasoring* VRC Vascular Ring ConnectorSunwei Tech Co., Ltd.20060

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?

  • Its one ancestor has no recall.
  • Of its descendants, K013664 (Coalescent Surgical, 2002) has gone furthest, with 44 descendants of its own.
  • 4 other devices also cite its predicate K970793.

How does its category compare?

All NCA devices

NCA Clip, Implantable, For Coronary Artery Bypass Graft (Cabg): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NCA

FDA has decided no NCA device since 2007.

Median 510(k) review, days · NCA

Too few NCA 510(k)s in any year since 2007 to give a median.

Recalls per year · NCA

No recall names NCA since 2007.

Adverse event reports per year · NCA

1in 2010

2007: 32009: 12010: 1
2007high 3 (2007) · low 0 (2008)2025

MAUDE reports naming product code NCA, 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
20070—03
20080—00
20090—01
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Aortic Connector System is intended to create the aortic anastomosis of aortic autologous vein grafts.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K970793

4 other devices cite the same predicate.

  • K030926Fast Throw Stainless Steel Surgical SutureAdvanced Surgical Products, Inc. · 2003
  • K011589Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad (2.0 to 4.0 MM Outer Diameter…Bypass, Ltd. · 2001
  • K013683Modification to: Abbott Vascular Suture Anastomosis DeviceAbbott Vascular, Inc. · 2001
  • K984438Modified Auto Suture*VCS** Anastomotic**Clip CartridgeUnited States Surgical, A Division of Tyco Healthc · 1999

Recent decisions in NCA

The NCA category page

  • K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002
  • K011589Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad (2.0 to 4.0 MM Outer Diameter…Bypass, Ltd. · 2001

https://510kreport.com/device/K003446 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003446: Symmetry Aortic Clip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003446

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026