510(k) · Cleared
Recalled · Class II · 2024Medtronic Clear Intravacular Arteriotomy Shunt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on May 25, 2012 as substantially equivalent to K993677 (Medtronic Vascular, 2000) after an 86-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- May 25, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993677 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK993677 Medtronic Clearview Intravascular Arteriotomy ShuntMedtronic Vascular · 2000
- This deviceK120612 Medtronic Clear Intravacular Arteriotomy ShuntMedtronic, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK253998 Clearview Intracoronary ShuntsMedtronic, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253998Clearview Intracoronary ShuntsMedtronic, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993677 | Medtronic Clearview Intravascular Arteriotomy Shunt | Medtronic Vascular | 2000 | — |
| 0 (this device) | K120612 | Medtronic Clear Intravacular Arteriotomy Shunt | Medtronic, Inc. | 2012 | — |
| +1 | K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993677 | Medtronic Clearview Intravascular Arteriotomy ShuntSummary page 1…ulation Number: 21 CFR 870.42 10 Product Code: DWF Classification: Class 11 Predicate Devices Medtronic Clearview® Intravascular Arteriotorny Shunt (K993677) AI/u%iau,2g Pain Restormlg .1-ea/ti;- Extentling Li/P Device Description Clearview® Intracoronary Shunts co… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253998 | Clearview Intracoronary Shunts | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2024 | Class II | Z-1803-2024 | Process control | Potential for unsealed sterile packing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K253998 (Medtronic, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
These shunts (Clearview® Intracoronary Shunts) are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120612: Medtronic Clear Intravacular Arteriotomy Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120612
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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