510(k) · Cleared
ClearedAmplatz Support Wire Guide with Apex Curve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DQX Wire, Guide, Catheter
Cleared on Jan 10, 2018 as substantially equivalent to K153397 (Concert Medical, LLC, 2016) after a 239-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jan 10, 2018
- Review
- 239 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930622 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK930622 Amplatz GuidewiresMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 3 generations backK130798 Pre-Formed GuidewiresLake Region Medical, Inc. · 2013
- 2 generations backK151244 Pre-Formed GuidewireLake Region Medical · 2015
- 1 generation backK153397 S-Wire Guidewire SystemConcert Medical, LLC · 2016
- This deviceK171445 Amplatz Support Wire Guide with Apex CurveCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930622 | Amplatz Guidewires | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −3 | K130798 | Pre-Formed Guidewires | Lake Region Medical, Inc. | 2013 | — |
| −2 | K151244 | Pre-Formed Guidewire | Lake Region Medical | 2015 | — |
| −1 | K153397 | S-Wire Guidewire System | Concert Medical, LLC | 2016 | — |
| 0 (this device) | K171445 | Amplatz Support Wire Guide with Apex Curve | Cook Incorporated | 2018 | — |
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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K153397 | S-Wire Guidewire SystemSummary page 4…21 CFR §870.1330 Product Code: DQX Predicate Devices: The predicate device is the S-Wire Guidewire System cleared for market under K153397, on August 18, 2016. Device Description: The Amplatz Support Wire Guide with Apex Curve, subject of this submission, is a Class… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The Amplatz Support Wire Guide with Apex Curve is used to facilitate the placement of devices during diagnostic and interventional procedures. The Amplatz Support Wire Guide with Apex Curve is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within trans-catheter aortic valve procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171445: Amplatz Support Wire Guide with Apex Curve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171445
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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