510(k) · Cleared
ClearedSLIM Microcatheter
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 Jul 13, 2026 as substantially equivalent to K210230 (Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular, 2021) after a 172-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jul 13, 2026
- Review
- 172 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945904 (1995). 13 ancestors in all, the oldest K862117 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
- 6 generations backK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
- 5 generations backK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
- 4 generations backK021591 Prowler Select (10, 14, and Plus) Infusion Catheters with and…Cordis Neurovascular, Inc. · 2002 · Recalled
- 3 generations backK151638 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom…Cathera, Inc. · 2015
- 2 generations backK180959 Phenom 27 CatheterCathera, Inc. · 2018
- 1 generation backK210230 Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021
- This deviceK260199 SLIM MicrocatheterBalt USA, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945904 | Scimed (R) Venture (TM) II Infusion Catheter | Scimed Peripheral Interventions | 1995 | — |
| −6 | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion Catheter | Cordis Neurovascular, Inc. | 1997 | — |
| −5 | K020680 | Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips | Cordis Neurovascular, Inc. | 2002 | — |
| −4 | K021591 | Prowler Select (10, 14, and Plus) Infusion Catheters with and Without… | Cordis Neurovascular, Inc. | 2002 | 2 |
| −3 | K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter | Cathera, Inc. | 2015 | — |
| −2 | K180959 | Phenom 27 Catheter | Cathera, Inc. | 2018 | — |
| −1 | K210230 | Phenom Catheters | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2021 | — |
| 0 (this device) | K260199 | SLIM Microcatheter | Balt USA, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K210230 | Phenom CathetersSummary page 5…tion Number: 21 CFR 870.1250, 21 CFR 870.1210 Device Class II Classification: Predicate Device: Phenom Catheters 510(k) #: K210230 Reference Device: NG Delivery Catheter 510(k) #: K230609 Headway Duo Microcatheter… | 2021 |
| † | K230609 | NG Delivery Catheter | 2023 |
| † | K120917 | Headway Duo Microcatheter | 2012 |
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 31 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K210230.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SLIM Microcatheter 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 in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260199: SLIM Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260199
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026