510(k) Report

510(k) · Cleared

Cleared

PVS 1700 Steerable Delivery System Microcatheter

K032494510(k) SpecialCleared Sep 5, 200323-day reviewClass II21 CFR 870.1210

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Precision Vascular Systems, Inc. · KRA Catheter, Continuous Flush

Cleared on Sep 5, 2003 as substantially equivalent to K020733 (Precision Vascular Systems, Inc., 2002) and 2 other predicates after a 23-day review. Its family tree reaches back 3 generations to 1996. 20 later devices descend from it.

Decided
Sep 5, 2003
Review
23 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K960806 (1996). 8 ancestors in all, the oldest K925813 (1994). 20 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 2 other ancestors1998: 1 other ancestor1994: 1 other ancestor2004: 2 descendants cleared2005: 2 descendants cleared2012: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2023: 1 descendant cleared2020: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK960806 · Turbo Tracker · Target Therapeutics · 1996K994155 · Excelsior 1018 Microcatheter · Boston Scientific, Target · 2000K013789 · Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 · Boston Scientific, Target · 2001 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 5 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants K013789 · Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 · Boston Scientific, Target · 2001 · recalledK994155 · Excelsior 1018 Microcatheter · Boston Scientific, Target · 2000K960806 · Turbo Tracker · Target Therapeutics · 19960+5
  1. Root · 3 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
  2. 2 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
  3. 1 generation backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
  4. This deviceK032494 PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
  5. Descendant · cites it directly · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
  6. Descendant · 2 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
  7. Descendant · 3 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
  8. Descendant · 3 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
  9. Descendant · 4 generations on · 5 of its ownK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2004: 22005: 22006: 12007: 22008: 22012: 22014: 12016: 12017: 12018: 12020: 22023: 12025: 12026: 1
2004high 2 (2004) · low 0 (2009)2026

Most influential descendants

Showing 5 of 20 · See all
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · cites it directly17descendants
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 2 generations on16descendants
  • K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 3 generations on9descendants
  • K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 3 generations on6descendants
  • K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K960806Turbo TrackerTarget Therapeutics1996—
−2K994155Excelsior 1018 MicrocatheterBoston Scientific, Target2000—
−1K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target20012
0 (this device)K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc.2003—
+1K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—
+2K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.2005—
+3K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.2006—
+3K080901Lbi Embolectomy SystemLumen Biomedical, Inc.2008—
+4K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199810
200020
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200520
200610
200720
200820
201220
201410
201610
201710
201810
202020
202310
202510
202610
FIG. 1 — Lineage of K032494, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K020733PVS 1500 SDS
Summary page 1
…edicate Concurrence Date Code Devices SDS 0.0 18” PVS, Inc. K020733,21 March 2002 KRA Excelsior SL-10 BSCnarget K013789,06 Dec 2001…
Precision Vascular Systems, Inc.2002—
*K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189
Summary page 1
…Devices SDS 0.0 18” PVS, Inc. K020733,21 March 2002 KRA Excelsior SL-10 BSCnarget K013789,06 Dec 2001 DQY Rebar-14 Micro Therapeutics K993672,04 Jan 2000…
Boston Scientific, Target20012
*K993672Rebar Micro Catheter, Models 105-5080, 105-5086
Summary page 1
…Excelsior SL-10 BSCnarget K013789,06 Dec 2001 DQY Rebar-14 Micro Therapeutics K993672,04 Jan 2000 KRA Classification Class II, 21 CFR 870.1210, Continuous Flush Catheter, KRA Performance…
Micro Therapeutics, Inc.2000—

Also cleared against K020733: 2 other devices →

What descends from it? (20)

See all 20

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417
K033726PVS Pivot Steerable Delivery System MicrocatheterPrecision Vascular20041
K050630Pivot Steerable MicrocatheterBoston Scientific - Precision Vascular20050

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 7 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K041123 (Kerberos Proximal Solutions, Inc., 2004) has gone furthest, with 17 descendants of its own.
  • 2 other devices also cite its predicate K020733.

How does its category compare?

All KRA devices

KRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRA

1in 2025

2007: 52008: 72009: 52010: 22011: 22012: 32013: 32014: 42016: 82017: 42018: 42019: 42020: 62021: 62022: 62023: 72025: 12026 (partial year): 5
2007high 8 (2016) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRA

63in 2023

2007: 44 days median2008: 144 days median2009: 69 days median2012: 29 days median2013: 126 days median2014: 61 days median2016: 122 days median2017: 166 days median2018: 178 days median2019: 133 days median2020: 29 days median2021: 108 days median2022: 228 days median2023: 63 days median2026 (partial year): 268 days median
2007high 268 (2026) · low 29 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KRA

41so far in 2026, the most since 2007

2007: 22008: 62009: 82010: 262011: 32012: 32013: 22014: 3, 2 Class I2015: 12016: 3, 1 Class I2019: 4, 4 Class I2020: 12023: 22026 (partial year): 41
2007high 41 (2026) · low 0 (2017)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KRA

980in 2025

2007: 1182008: 1172009: 1872010: 3552011: 2392012: 2172013: 2092014: 2762015: 3392016: 4182017: 5382018: 4342019: 4182020: 3812021: 4402022: 5432023: 8292024: 9422025: 980
2007high 980 (2025) · low 117 (2008)2025

MAUDE reports naming product code KRA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075442118
200871446117
20095698187
20102—26355
20112—3239
20123293217
201331262209
20144613 (2)276
20150—1339
201681223 (1)418
201741660538
201841780434
201941334 (4)418
20206291381
202161080440
202262280543
20237632829
20240—0942
20251—0980
2026526841—

What is it indicated for?

The PVS 1700 Steerable Delivery System-10 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 guide wire exchange/support during diagnostic or interventional procedures.

Indications for use as stated in the FDA summary.

Also cleared against K020733

2 other devices cite the same predicate.

  • K050630Pivot Steerable MicrocatheterBoston Scientific - Precision Vascular · 20051 recall
  • K033726PVS Pivot Steerable Delivery System MicrocatheterPrecision Vascular · 2004

More from Precision Vascular Systems, Inc.

7 FDA decisions under this applicant name. See the company

  • K032146PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 20031 recall
  • K023700PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc. · 20021 recall
  • K020733PVS 1500 SDSPrecision Vascular Systems, Inc. · 2002
  • K002907PVS 1300 Neuro Guide WirePrecision Vascular Systems, Inc. · 20011 recall
  • K002707PVS 1400 Guide Wite with Hydrophilic CoatingPrecision Vascular Systems, Inc. · 2000

Recent decisions in KRA

The KRA category page

  • K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
  • K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
  • K261610Verge™ MicrocatheterInstylla, Inc. · 2026
  • K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026
  • K250794InVera Infusion DeviceInvera Medical · 2026

https://510kreport.com/device/K032494 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032494: PVS 1700 Steerable Delivery System Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032494

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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