510(k) · Cleared
Recalled · 2009Renegade Fiber Braided Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KRA Catheter, Continuous Flush
Cleared on Nov 19, 1997 after a 56-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 19, 1997
- Review
- 56 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 2
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK973645 Renegade Fiber Braided MicrocatheterBoston Scientific Corp · 1997
- Descendant · cites it directly · 7 of its ownK082613 Merit MicrocatheterMerit Medical Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 4 of its ownK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK190126 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019
- Descendant · 4 generations on · 1 of its ownK200582 Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK172081 Maestro MicrocatheterMerit Medical Systems, Inc. · 2017 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K082613Merit MicrocatheterMerit Medical Systems, Inc. · 2008 · cites it directly7descendants
- K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016 · 2 generations on4descendants
- K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2019 · 3 generations on2descendants
- K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd. · 2020 · 4 generations on1descendant
- K172081Maestro MicrocatheterMerit Medical Systems, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973645 | Renegade Fiber Braided Microcatheter | Boston Scientific Corp | 1997 | — |
| +1 | K082613 | Merit Microcatheter | Merit Medical Systems, Inc. | 2008 | 2 |
| +2 | K161921 | SwiftNINJA Microcatheter | Merit Medical Systems, Inc. | 2016 | — |
| +3 | K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2019 | — |
| +4 | K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020 | — |
| +2 | K172081 | Maestro Microcatheter | Merit Medical Systems, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 KRA? 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 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 |
|---|---|---|---|
| * | — | Evolution Microcatheter Named without a submission number | |
| * | — | Eddy Infusion Named without a submission number | |
| * | — | TurboTracker Infusion Catheter Named without a submission number | |
| * | — | Venture II Intravascular infusion catheters Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082613 | Merit Microcatheter | 2008 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2009 | Not classified | Z-0358-2011 | Packaging process control | Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection. |
| Oct 13, 2006 | Not classified | Z-0177-2007 | Other | Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082613 (Merit Medical Systems, Inc., 2008) has gone furthest, with 7 descendants of its own.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The Renegade Fiber Braided 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 the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.
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/K973645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973645: Renegade Fiber Braided Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973645
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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