510(k) Report

510(k) · Cleared

Cleared

PVS 1500 SDS

K020733510(k) TraditionalCleared Mar 21, 200215-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 Mar 21, 2002 as substantially equivalent to K960806 (Target Therapeutics, 1996) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1996. 21 later devices descend from it.

Decided
Mar 21, 2002
Review
15 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K960806 (1996). 2 ancestors in all. 21 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2003: 1 descendant cleared2005: 2 descendants cleared2004: 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 · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 4 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants7 generations forward: 3 descendants K960806 · Turbo Tracker · Target Therapeutics · 19960+5
  1. Root · 1 generation backK960806 Turbo TrackerTarget Therapeutics · 1996
  2. This deviceK020733 PVS 1500 SDSPrecision Vascular Systems, Inc. · 2002
  3. Descendant · cites it directly · 20 of its ownK032494 PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
  4. Descendant · 2 generations on · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
  5. Descendant · 3 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
  6. Descendant · 4 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
  7. Descendant · 4 generations on · 6 of its ownK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 22006: 12007: 22008: 22012: 22014: 12016: 12017: 12018: 12020: 22023: 12025: 12026: 1
2003high 2 (2004) · low 0 (2009)2026

Most influential descendants

Showing 5 of 21 · See all
  • K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003 · cites it directly20descendants
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · 2 generations on17descendants
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 3 generations on16descendants
  • K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 4 generations on9descendants
  • K080901Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960806Turbo TrackerTarget Therapeutics1996—
0 (this device)K020733PVS 1500 SDSPrecision Vascular Systems, Inc.2002—
+1K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc.2003—
+2K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—
+3K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.2005—
+4K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.2006—
+4K080901Lbi Embolectomy SystemLumen Biomedical, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200520
200610
200720
200820
201220
201410
201610
201710
201810
202020
202310
202510
202610
FIG. 1 — Lineage of K020733, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 14.5 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K960806Turbo Tracker
Summary page 1
…The predicate devices are listed in the table below. . : 510(k) ‘Number, Product Pl;g‘c:;g:;e Device Manufacturer Concurence Date Code FasTracker-18 Target Therapeutics K960806, 02 May 1996* DQO Rebar-18 Micro Therapeutics K0019686, 20 Jui 2000 KRA * This information is assumed based on our best, current…
Target Therapeutics1996—
*K001966Rebar Micro Catheter: Rebar-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and…
Our OCR of the scanned summary read K001968, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Rebar-18”.
Micro Therapeutics, Inc.2000—

Also cleared against K960806: 7 other devices →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc.200320
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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K032494 (Precision Vascular Systems, Inc., 2003) has gone furthest, with 20 descendants of its own.
  • 7 other devices also cite its predicate K960806.

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 1500 SDS is intended for use in accessing distal peripheral, coronary, and neurovasculature for the sub-selective, controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K960806

7 other devices cite the same predicate.

  • K063620Ekos Micro-Infusion SystemEkos Corp. · 2007
  • K041826Ekos Ultrasound Infusion SystemEkos Corp. · 2005
  • K032624Micrus MicrocatheterMicrus Corp. · 2003
  • K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003
  • K994155Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
  • K993292Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target · 2000

More from Precision Vascular Systems, Inc.

7 FDA decisions under this applicant name. See the company

  • K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
  • 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
  • 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/K020733 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020733: PVS 1500 SDS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020733

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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