510(k) · Cleared
ClearedCTS Midcab Fixedn Diameter Coronary Shunt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiothoracic Systems, Inc. · DXC Clamp, Vascular
Cleared on Oct 30, 1997 after a 252-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Oct 30, 1997
- Review
- 252 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK970638 CTS Midcab Fixedn Diameter Coronary ShuntCardiothoracic Systems, Inc. · 1997
- Descendant · cites it directly · 13 of its ownK061075 Boomerang WireCardiva Medical, Inc. · 2006
- Descendant · 2 generations on · 12 of its ownK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 11 of its ownK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 10 of its ownK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- Descendant · 5 generations on · 9 of its ownK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K061075Boomerang WireCardiva Medical, Inc. · 2006 · cites it directly13descendants
- K091006Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · 2 generations on12descendants
- K100615Arstasis Access SystemArstasis, Inc. · 2010 · 3 generations on11descendants
- K102728Arstasis Access SystemArstasis, Inc. · 2010 · 4 generations on10descendants
- K103143Arstasis One Latchwire Access SystemArstasis, Inc. · 2011 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970638 | CTS Midcab Fixedn Diameter Coronary Shunt | Cardiothoracic Systems, Inc. | 1997 | — |
| +1 | K061075 | Boomerang Wire | Cardiva Medical, Inc. | 2006 | — |
| +2 | K091006 | Itg Vascular Access System, Model 300 | Arstasis, Inc. | 2010 | 1 |
| +3 | K100615 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| +4 | K102728 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| +5 | K103143 | Arstasis One Latchwire Access System | Arstasis, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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 DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Bio-Vascular, Inc. Flo-Rester Named without a submission number | |
| * | — | Research Medical, Inc. Yacoubian Clamp External Coronary Artery Occluder Named without a submission number | |
| * | — | Research Medical, Inc. Carotid Artery Shunts Named without a submission number | |
| * | — | Research Medical, Inc. Vacu-Sponge Surgical Sponge Named without a submission number |
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K061075 (Cardiva Medical, Inc., 2006) has gone furthest, with 13 descendants of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
The CTS FloCoil Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.
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/K970638 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970638: CTS Midcab Fixedn Diameter Coronary Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970638
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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