510(k) · Cleared
Recalled · 2006Pivot Steerable Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific - Precision Vascular · KRA Catheter, Continuous Flush
Cleared on Mar 22, 2005 as substantially equivalent to K020733 (Precision Vascular Systems, Inc., 2002) and 2 other predicates after an 11-day review. Its family tree reaches back 5 generations to 1996. It has been recalled once.
- Decided
- Mar 22, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K960806 (1996). 10 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 4 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 3 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 2 generations backK032494 PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
- 1 generation backK033726 PVS Pivot Steerable Delivery System MicrocatheterPrecision Vascular · 2004
- This deviceK050630 Pivot Steerable MicrocatheterBoston Scientific - Precision Vascular · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −4 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −3 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −2 | K032494 | PVS 1700 Steerable Delivery System Microcatheter | Precision Vascular Systems, Inc. | 2003 | — |
| −1 | K033726 | PVS Pivot Steerable Delivery System Microcatheter | Precision Vascular | 2004 | — |
| 0 (this device) | K050630 | Pivot Steerable Microcatheter | Boston Scientific - Precision Vascular | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 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? (3)
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 |
|---|---|---|---|
| * | K020733 | PVS 1500 SDSSummary page 1…cate Device Manufacturer 510(k) Number/Date Pro Code Devices SDS 0.018" PVS, Inc. K020733, 21 March 2002 KRA SDS 0.010" PVS, Inc. K032494, 05 Sep 2003 K… | 2002 |
| * | K032494 | PVS 1700 Steerable Delivery System MicrocatheterSummary page 1…Devices SDS 0.018" PVS, Inc. K020733, 21 March 2002 KRA SDS 0.010" PVS, Inc. K032494, 05 Sep 2003 KRA Pivot "SDS" PVS, Inc. K033726, 16 Jan 2004 K… | 2003 |
| * | K033726 | PVS Pivot Steerable Delivery System MicrocatheterSummary page 1…SDS 0.010" PVS, Inc. K032494, 05 Sep 2003 KRA Pivot "SDS" PVS, Inc. K033726, 16 Jan 2004 KRA Classification Class II,21 CFR 870.1210, Continuous Flush Catheter, KRA Performance Perf… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2006 | Not classified | Z-0895-06 | Other | During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K020733.
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 "PivotTM" Steerable Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guidewire exchange/support during diagnostic or interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050630: Pivot Steerable Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050630
Report an extraction error
Are you the manufacturer?
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