510(k) · Cleared

Cleared

Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad (2.0 to 4.0 MM Outer Diameter Vessels), M

K011589510(k) TraditionalCleared Dec 26, 2001217-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

Bypass, Ltd. · NCA Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

Cleared on Dec 26, 2001 as substantially equivalent to K970793 (United States Surgical, A Division of Tyco Healthc, 1997) and 2 other predicates after a 217-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.

Decided: Dec 26, 2001
Review: 217 days
Class: Class II
Product code: NCA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K864146 (1986). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK864146 Deknatel Gwathmey Vascular Stapling Kit (Tenative)Cardio Thoracic Systems · 1986
This deviceK011589 Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064…Bypass, Ltd. · 2001
Descendant · cites it directly · 1 of its ownK020470 Modification to Corlink Automated Anastomotic DeviceBypass, Ltd. · 2002
Descendant · 2 generations on · 0 of its ownK033979 Corlink Automated Anastomotic SystemBy-Pass Makafim, Ltd. · 2004

Most influential descendants

Showing 2 of 2 · See all

K020470Modification to Corlink Automated Anastomotic DeviceBypass, Ltd. · 2002 · cites it directly1descendant
K033979Corlink Automated Anastomotic SystemBy-Pass Makafim, Ltd. · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864146	Deknatel Gwathmey Vascular Stapling Kit (Tenative)	Cardio Thoracic Systems	1986	—
0 (this device)	K011589	Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad…	Bypass, Ltd.	2001	—
+1	K020470	Modification to Corlink Automated Anastomotic Device	Bypass, Ltd.	2002	—
+2	K033979	Corlink Automated Anastomotic System	By-Pass Makafim, Ltd.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0

FIG. 1 — Lineage of K011589, 1986–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 NCA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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? (3)

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	Applicant	Decided	Recalls
*	K970793	Implantable Clip Summary page 4 …Classification Name: Implantable Clip Product Code: FZP Predicate Devices: The ByPass CorLink™ AAD is substantially equivalent to the USSC One-Shot Sutureless System (K970793), the USSC Auto Suture Vascular Anastomosis Clip (K933887) and the Deknatel Gwathmey Vascular Stapling Kit (K864146). Indication…	United States Surgical, A Division of Tyco Healthc	1997	—
*	K933887	Implantable Clip Summary page 4 …Predicate Devices: The ByPass CorLink™ AAD is substantially equivalent to the USSC One-Shot Sutureless System (K970793), the USSC Auto Suture Vascular Anastomosis Clip (K933887) and the Deknatel Gwathmey Vascular Stapling Kit (K864146). Indication for Use: The ByPass CorLink™ Anastomotic Device is inten…	United States Surgical, A Division of Tyco Healthc	1993	—
*	K864146	Deknatel Gwathmey Vascular Stapling Kit (Tenative) Summary page 4 …ly equivalent to the USSC One-Shot Sutureless System (K970793), the USSC Auto Suture Vascular Anastomosis Clip (K933887) and the Deknatel Gwathmey Vascular Stapling Kit (K864146). Indication for Use: The ByPass CorLink™ Anastomotic Device is intended to create vascular anastomoses between blood vessels.…	Cardio Thoracic Systems	1986	—

Also cleared against K970793: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020470	Modification to Corlink Automated Anastomotic Device	Bypass, Ltd.	2002	1

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?

None of the 3 ancestors has a recall.
Of its descendants, K020470 (Bypass, Ltd., 2002) has gone furthest, with 1 descendant 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

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	3
2008	—	0
2009	—	1
2010	—	1
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The ByPass CorLink™ Anastomotic Device is intended to create vascular anastomoses between blood vessels. Specifically, the device is indicated for creation of a sutureless proximal anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG) procedures.

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

https://510kreport.com/device/K011589 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011589: Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad (2.0 to 4.0 MM Outer Diameter Vessels), M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011589

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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