510(k) Report

510(k) · Cleared

Cleared

Microferret Catheter

K961668510(k) TraditionalCleared Nov 4, 1996188-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

Cook, Inc. · KRA Catheter, Continuous Flush

Cleared on Nov 4, 1996 as substantially equivalent to K853997 (Target Therapeutics, 1985) and 4 other predicates after a 188-day review. Its family tree reaches back 1 generation to 1985.

Decided
Nov 4, 1996
Review
188 days
Class
Class II
Product code
KRA
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K853997 (1985). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1988: 1 other ancestor1986: 1 other ancestorK853997 · Infusion Catheter · Target Therapeutics · 19851986198819901992199419961998
Other ancestors, by generation 1 generation back: 4 other ancestors K853997 · Infusion Catheter · Target Therapeutics · 19850
  1. Root · 1 generation backK853997 Infusion CatheterTarget Therapeutics · 1985
  2. This deviceK961668 Microferret CatheterCook, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K853997Infusion CatheterTarget Therapeutics1985—
0 (this device)K961668Microferret CatheterCook, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198810
199410
199510
FIG. 1 — Lineage of K961668, 1985–1996Source: 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 14.5 · 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? (6)

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
*K853997Infusion Catheter
Summary page 1
…ndications for use, design, construction and materials equivalence. Specifically, this device is similar to numerous pre-Amendment COOK catheters, Tracker™ catheters (K#853997, K#862117, K#874751), manufactured by Target Therapeutics®, San Jose, California, Evolution™ Microcatheters (K#953114) manufactu…
Target Therapeutics1985—
*K862117Tracker Infusion Catheter
Summary page 1
…for use, design, construction and materials equivalence. Specifically, this device is similar to numerous pre-Amendment COOK catheters, Tracker™ catheters (K#853997, K#862117, K#874751), manufactured by Target Therapeutics®, San Jose, California, Evolution™ Microcatheters (K#953114) manufactured by Bos…
Target Therapeutics1986—
*K874751Tracker-25 Infusion Catheter
Summary page 1
…design, construction and materials equivalence. Specifically, this device is similar to numerous pre-Amendment COOK catheters, Tracker™ catheters (K#853997, K#862117, K#874751), manufactured by Target Therapeutics®, San Jose, California, Evolution™ Microcatheters (K#953114) manufactured by Boston Scient…
Target Therapeutics1988—
*K953114Evolution Microcatheter
Summary page 1
…re-Amendment COOK catheters, Tracker™ catheters (K#853997, K#862117, K#874751), manufactured by Target Therapeutics®, San Jose, California, Evolution™ Microcatheters (K#953114) manufactured by Boston Scientific, Watertown, Massachusetts, Venture™ Infusion Catheters (K#931335) manufactured by Scimed Life…
Boston Scientific Corp1995—
*K931335Scimed (R) Venture (TM) Infusion Catheter
Summary page 1
…t Therapeutics®, San Jose, California, Evolution™ Microcatheters (K#953114) manufactured by Boston Scientific, Watertown, Massachusetts, Venture™ Infusion Catheters (K#931335) manufactured by Scimed Life Systems and distributed by Boston Scientific, Watertown, Massachusetts and others. Device Descripti…
Scimed Life Systems, Inc.1994—
*—pre-Amendment COOK catheters
Named without a submission number
—

Also cleared against K853997: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 5 ancestors has a recall.
  • 1 other device also cites its predicate K853997.

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 Microferret™ catheter is used for percutaneous access to small vessel, distal anatomy.

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 K853997

1 other device cites the same predicate.

  • K052637Therox Infusion Catheter, Model Inca-1Therox, Inc. · 2006

More from Cook, Inc.

285 FDA decisions under this applicant name. See the company

  • P020018/S070Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac BranchCook, Inc. · 2026
  • P020018/S069Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN); Zenith Iliac Branch…Cook, Inc. · 2026
  • P020018/S068Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular…Cook, Inc. · 2026
  • P020018/S067Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith…Cook, Inc. · 2026
  • P020018/S066Zenith Flex AAA Endovascular System and Zenith Iliac BranchCook, Inc. · 2026

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/K961668 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961668: Microferret Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961668

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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