510(k) · Cleared
Recalled · 2009Renegade STC 18 Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQO Catheter, Intravascular, Diagnostic
Cleared on Nov 26, 2002 after a 25-day review. The FDA summary names its predicate without a number. 2 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled once.
- Decided
- Nov 26, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 3 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- This deviceK023681 Renegade STC 18 MicrocatheterBoston Scientific Corp · 2002
- Descendant · cites it directly · 2 of its ownK121694 Imager II Angiographic CatheterBoston Scientific Corp · 2012 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK112124 MicrocatheterNavilyst Medical, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK133130 Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK161822 Torcon NB Advantage CathetersCook Incorporated · 2016
- Descendant · 2 generations on · 0 of its ownK121954 Nmi MicrocatheterNavilyst Medical, Inc. · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K121694Imager II Angiographic CatheterBoston Scientific Corp · 2012 · cites it directly2descendants
- K112124MicrocatheterNavilyst Medical, Inc. · 2011 · cites it directly2descendants
- K133130Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · 2 generations on1descendant
- K161822Torcon NB Advantage CathetersCook Incorporated · 2016 · 3 generations on0descendants
- K121954Nmi MicrocatheterNavilyst Medical, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023681 | Renegade STC 18 Microcatheter | Boston Scientific Corp | 2002 | — |
| +1 | K121694 | Imager II Angiographic Catheter | Boston Scientific Corp | 2012 | Class I |
| +1 | K112124 | Microcatheter | Navilyst Medical, Inc. | 2011 | — |
| +2 | K133130 | Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter | Cook, Inc. | 2015 | Class I |
| +3 | K161822 | Torcon NB Advantage Catheters | Cook Incorporated | 2016 | — |
| +2 | K121954 | Nmi Microcatheter | Navilyst Medical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 1 |
| 2015 | 1 | 1 |
| 2016 | 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.
2 devices in this family have a Class I recall. 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | — | Renegade Hi-Flo Microcatheter Named without a submission number | |
| * | — | Renegade Fiber Braided Microcatheter Named without a submission number | |
| * | — | Excelsior 1018 Microcatheter Named without a submission number | |
| * | — | Tracker Excel 14 Named without a submission number |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2009 | Not classified | Z-2244-2009 | Packaging | Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121694Imager II Angiographic CatheterBoston Scientific Corp · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K133130Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K121694 (Boston Scientific Corp, 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Renegade STCTM 18 Microcatheter is intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023681 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023681: Renegade STC 18 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023681
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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