510(k) Report

510(k) · Cleared

Cleared

Rebar Micro Catheter: Rebar-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and 153 CM, Dual Marker Band

K001966510(k) SpecialCleared Jul 20, 200022-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 Jul 20, 2000 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.

Decided
Jul 20, 2000
Review
22 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
0

29 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2012: 3 descendants cleared2002: 1 descendant cleared2009: 1 descendant cleared2003: 1 descendant cleared2005: 2 descendants cleared2004: 2 descendants cleared2021: 1 descendant cleared2020: 3 descendants cleared2013: 1 descendant cleared2017: 2 descendants cleared2025: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2007: 2 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2023: 1 descendant cleared2016: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK001966 Rebar Micro Catheter: Rebar-18 [2.3F], 110 CM, 130 CM, 153 CM…Micro Therapeutics, Inc. · 2000
  2. Descendant · cites it directly · 21 of its ownK020733 PVS 1500 SDSPrecision Vascular Systems, Inc. · 2002
  3. Descendant · 2 generations on · 20 of its ownK032494 PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003
  4. Descendant · 3 generations on · 17 of its ownK041123 Rinspiration System,Rinspiration System Short Tip, Models…Kerberos Proximal Solutions, Inc. · 2004
  5. Descendant · 4 generations on · 16 of its ownK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
  6. Descendant · 5 generations on · 9 of its ownK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 22005: 22006: 12007: 22008: 22009: 12012: 32013: 12014: 12016: 12017: 22018: 12020: 32021: 12023: 12025: 22026: 1
2002high 3 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 29 · See all
  • K020733PVS 1500 SDSPrecision Vascular Systems, Inc. · 2002 · cites it directly21descendants
  • K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc. · 2003 · 2 generations on20descendants
  • K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc. · 2004 · 3 generations on17descendants
  • K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005 · 4 generations on16descendants
  • K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001966Rebar Micro Catheter: Rebar-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker…Micro Therapeutics, Inc.2000—
+1K020733PVS 1500 SDSPrecision Vascular Systems, Inc.2002—
+2K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc.2003—
+3K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.2004—
+4K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.2005—
+5K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200420
200520
200610
200720
200820
200910
201230
201310
201410
201610
201720
201810
202030
202110
202310
202520
202610
FIG. 1 — Lineage of K001966, 2000–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K020733PVS 1500 SDSPrecision Vascular Systems, Inc.200221
K093750Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC…Ev3, Inc.20093
K122684Reverse Medical MicrocatheterReverse Medical Corporation20122

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?

  • Of its descendants, K020733 (Precision Vascular Systems, Inc., 2002) has gone furthest, with 21 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—

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/K001966 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001966: Rebar Micro Catheter: Rebar-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and 153 CM, Dual Marker Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001966

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026