510(k) Report

510(k) · Cleared

Cleared

Rebar Micro Catheter, Models 105-5080, 105-5086

K993672510(k) SpecialCleared Jan 4, 200064-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

Micro Therapeutics, Inc. · KRA Catheter, Continuous Flush

Cleared on Jan 4, 2000 as substantially equivalent to K974473 (Micro Therapeutics, Inc., 1998) after a 64-day review. Its family tree reaches back 1 generation to 1998. 39 later devices descend from it.

Decided
Jan 4, 2000
Review
64 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K974473 (1998). 39 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2003: 4 descendants cleared2012: 4 descendants cleared2009: 2 descendants cleared2002: 1 descendant cleared2006: 2 descendants cleared2004: 4 descendants cleared2005: 2 descendants cleared2021: 1 descendant cleared2020: 3 descendants cleared2015: 2 descendants cleared2019: 1 descendant cleared2017: 2 descendants cleared2025: 2 descendants cleared2008: 2 descendants cleared2007: 2 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2023: 1 descendant cleared2016: 1 descendant cleared2026: 1 descendant clearedK974473 · Easy Rider Micro Catheter · Micro Therapeutics, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 11 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants7 generations forward: 3 descendants K974473 · Easy Rider Micro Catheter · Micro Therapeutics, Inc. · 19980+5
  1. Root · 1 generation backK974473 Easy Rider Micro CatheterMicro Therapeutics, Inc. · 1998
  2. This deviceK993672 Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000
  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 · cites it directly · 9 of its ownK030688 Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc. · 2003 · Recalled

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2002: 12003: 42004: 42005: 22006: 22007: 22008: 22009: 22012: 42014: 12015: 22016: 12017: 22018: 12019: 12020: 32021: 12023: 12025: 22026: 1
2002high 4 (2003) · low 0 (2010)2026

Most influential descendants

Showing 5 of 39 · 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
  • K030688Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc. · 2003 · cites it directly9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K974473Easy Rider Micro CatheterMicro Therapeutics, Inc.1998—
0 (this device)K993672Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc.2000—
+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—
+1K030688Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc.20032

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200340
200440
200520
200620
200720
200820
200920
201240
201410
201520
201610
201720
201810
201910
202030
202110
202310
202520
202610
FIG. 1 — Lineage of K993672, 1998–2026Source: 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 14.4 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K974473Easy Rider Micro Catheter
Summary page 1
…utics, Inc. CONTACT: 2 Goodyear Irvine, CA 92618 Tom Daughters Regulatory Affairs (949) 837-3700 PREDICATE DEVICE Micro Therapeutics, Inc. Easy Rider Micro Catheter, K974473 DEVICE DESCRIPTION The Rebar Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire int…
Micro Therapeutics, Inc.1998—

What descends from it? (39)

See all 39

8 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
K030688Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc.20039
K051990Echelon Micro CatheterMicro Therapeutics, Inc.20065
K022003Titan Micro Catheter, Model 105-5074-153; HD Injector, Model 103-0305Micro Therapeutics, Inc.20025
K024122Nautica Micro Catheter, Model 105-5094-153Micro Therapeutics, Inc.20034
K113289Orion Micro CatheterMicro Therapeutics, Inc.20123
K093750Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC…Ev3, Inc.20093
K121734Plato Microcath 27 MicrocatheterScientia Vascular, LLC20121

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?

  • Its one ancestor has no recall.
  • Of its descendants, K032494 (Precision Vascular Systems, Inc., 2003) has gone furthest, with 20 descendants of its own.

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 Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.

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

More from Micro Therapeutics, Inc.

51 FDA decisions under this applicant name. See the company

  • K113289Orion Micro CatheterMicro Therapeutics, Inc. · 2012
  • K11345414 Wire Standard, 14 Wire LSMicro Therapeutics, Inc. · 2012
  • K090870Echelon Micro Catheter, Models 105-5092-150SA, 145-5092-150SA and 190-5092-150SA and Syringe Adapter AccessoryMicro Therapeutics, Inc. · 2009
  • K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc. · 2009
  • K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 20082 recalls

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/K993672 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993672: Rebar Micro Catheter, Models 105-5080, 105-5086.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993672

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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