510(k) · Cleared
ClearedNG Delivery Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Balt USA, LLC · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Sep 13, 2023 as substantially equivalent to K172014 (MicroVention, Inc., 2018) after a 191-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Sep 13, 2023
- Review
- 191 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K960806 (1996). 8 ancestors in all, the oldest K925813 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 5 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 4 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 3 generations backK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- 2 generations backK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
- 1 generation backK172014 Wedge MicrocatheterMicroVention, Inc. · 2018
- This deviceK230609 NG Delivery CatheterBalt USA, LLC · 2023
- Descendant · cites it directly · 0 of its ownK252569 Carrier XL Delivery CatheterBalt USA, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K252569Carrier XL Delivery CatheterBalt USA, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −5 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −4 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −3 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| −2 | K093160 | Headway 21 Microcatheter, Model: MC212150S | MicroVention, Inc. | 2009 | — |
| −1 | K172014 | Wedge Microcatheter | MicroVention, Inc. | 2018 | — |
| 0 (this device) | K230609 | NG Delivery Catheter | Balt USA, LLC | 2023 | — |
| +1 | K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 QJP? 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 QJP device
- #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 6 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 |
|---|---|---|---|
| * | K172014 | Wedge MicrocatheterSummary page 4…Regulation Number: 21 CFR 870.1250 Device Classification: Class II Predicate Device: Wedge Microcatheter 510(k) #: K172014 Reference Device: AXS Offset Delivery Assist Catheter 510(k) #: K163259 Device Descripti… | 2018 |
| † | K163259 | AXS Offset Delivery Assist Catheter | 2017 |
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 |
|---|---|---|---|
| K252569 | Carrier XL Delivery Catheter | 2025 | 0 |
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 27 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K252569 (Balt USA, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K172014.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QJP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJP
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJP
688in 2025
MAUDE reports naming product code QJP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 9 | 72 | 0 | 16 |
| 2021 | 12 | 139 | 0 | 29 |
| 2022 | 14 | 206 | 0 | 30 |
| 2023 | 14 | 184 | 0 | 75 |
| 2024 | 18 | 188 | 1 | 130 |
| 2025 | 14 | 116 | 0 | 688 |
| 2026 | 22 | 141 | 0 | — |
What is it indicated for?
The NG Delivery Catheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230609: NG Delivery Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230609
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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