510(k) · Cleared
ClearedPVS Pivot Steerable Delivery System Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Vascular · KRA Catheter, Continuous Flush
Cleared on Jan 16, 2004 as substantially equivalent to K020733 (Precision Vascular Systems, Inc., 2002) and 1 other predicate after a 49-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Jan 16, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960806 (1996). 9 ancestors in all, the oldest K925813 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 3 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 2 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 1 generation backK032494 PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
- This deviceK033726 PVS Pivot Steerable Delivery System MicrocatheterPrecision Vascular · 2004
- Descendant · cites it directly · 0 of its ownK050630 Pivot Steerable MicrocatheterBoston Scientific - Precision Vascular · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K050630Pivot Steerable MicrocatheterBoston Scientific - Precision Vascular · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −3 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −2 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −1 | K032494 | PVS 1700 Steerable Delivery System Microcatheter | Precision Vascular Systems, Inc. | 2003 | — |
| 0 (this device) | K033726 | PVS Pivot Steerable Delivery System Microcatheter | Precision Vascular | 2004 | — |
| +1 | K050630 | Pivot Steerable Microcatheter | Boston Scientific - Precision Vascular | 2005 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 14.5 · 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? (2)
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…Devices Device Manufacturer Concurrence Date Code SDS 0.0 18" PVS, Inc. K020733, 21 March 2002 KRA SDS 0.0 10" PVS, Inc. K032494, 05 Sep 2003… | 2002 |
| * | K032494 | PVS 1700 Steerable Delivery System MicrocatheterSummary page 1…SDS 0.0 18" PVS, Inc. K020733, 21 March 2002 KRA SDS 0.0 10" PVS, Inc. K032494, 05 Sep 2003 KRA Classification Class II, 21 CFR 870.1210, Continuous Flush Catheter, KRA Performance Per… | 2003 |
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 |
|---|---|---|---|
| K050630 | Pivot Steerable Microcatheter | 2005 | 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 8 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K050630 (Boston Scientific - Precision Vascular, 2005) has gone furthest, with 0 descendants of its own.
- 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 PVS "PivotTM" Steerable Delivery System® 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/K033726 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033726: PVS Pivot Steerable Delivery System Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033726
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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