510(k) Report

510(k) · Cleared

Cleared

CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set

K221934510(k) TraditionalCleared Mar 9, 2023251-day reviewClass II21 CFR 870.1250

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

Cerenovus, Inc. · NRY Catheter, Thrombus Retriever

Cleared on Mar 9, 2023 as substantially equivalent to K193380 (Codman & Shurtleff, Inc., 2020) after a 251-day review. Its family tree reaches back 10 generations to 2001. 1 later device descends from it.

Decided
Mar 9, 2023
Review
251 days
Class
Class II
Product code
NRY
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K003410 (2001). 27 ancestors in all, the oldest K003880 (2001). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2019: 2 other ancestors2018: 1 other ancestor2015: 1 other ancestor2014: 2 other ancestors2011: 2 other ancestors2009: 2 other ancestors2012: 1 other ancestor2008: 1 other ancestor2001: 3 other ancestors2010: 1 other ancestor2002: 1 other ancestor2025: 1 descendant clearedReference device: K173200 · SOFIA Plus Aspiration Catheter · MicroVention, Inc. · 2018K003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalledK030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK033736 · Merci Retriever, Models 90065, 90066 · Concentric Medical, Inc. · 2004K072718 · Penumbra System · Penumbra, Inc. · 2007 · recalledK100769 · Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 · Penumbra, Inc. · 2010K113163 · Penumbra System Max · Penumbra, Inc. · 2011K142458 · Penumbra System ACE · Penumbra, Inc. · 2015K152541 · Penumbra System ACE 64 and ACE 68 Reperfusion Catheters · Penumbra, Inc. · 2016K161064 · Penumbra System ACE 68 Reperfusion Catheter · Penumbra, Inc. · 2016K193380 · CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set · Codman & Shurtleff, Inc. · 2020200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 2 other ancestors5 generations back: 6 other ancestors6 generations back: 3 other ancestors7 generations back: 2 other ancestors8 generations back: 2 other ancestors 1 generation forward: 1 descendant K193380 · CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set · Codman & Shurtleff, Inc. · 2020K161064 · Penumbra System ACE 68 Reperfusion Catheter · Penumbra, Inc. · 2016K152541 · Penumbra System ACE 64 and ACE 68 Reperfusion Catheters · Penumbra, Inc. · 2016K142458 · Penumbra System ACE · Penumbra, Inc. · 2015K113163 · Penumbra System Max · Penumbra, Inc. · 2011K100769 · Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 · Penumbra, Inc. · 2010K072718 · Penumbra System · Penumbra, Inc. · 2007 · recalledK033736 · Merci Retriever, Models 90065, 90066 · Concentric Medical, Inc. · 2004K030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalled−10−50
  1. Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 6 generations between
  3. 3 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
  4. 2 generations backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
  5. 1 generation backK193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
  6. This deviceK221934 CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2023
  7. Descendant · cites it directly · 0 of its ownK251828 CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2025
Show all 10 generations
  1. Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 9 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 8 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
  4. 7 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
  5. 6 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
  6. 5 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
  7. 4 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
  8. 3 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
  9. 2 generations backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
  10. 1 generation backK193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
  11. This deviceK221934 CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K003410Concentric Retriever, Model 90030Concentric Medical, Inc.20011
−9K030476Modified Concentric Retriever, Model 90037Concentric Medical, Inc.20032
−8K033736Merci Retriever, Models 90065, 90066Concentric Medical, Inc.2004—
−7K072718Penumbra SystemPenumbra, Inc.20071
−6K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032…Penumbra, Inc.2010—
−5K113163Penumbra System MaxPenumbra, Inc.2011—
−4K142458Penumbra System ACEPenumbra, Inc.2015—
−3K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc.2016—
−2K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.2016—
−1K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.2020—
0 (this device)K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.2023—
+1K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200130
200210
200810
200920
201010
201120
201210
201420
201510
201810
201920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K221934, 2001–2025Source: 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 NRY? 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 NRY device

  1. #1 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 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
*K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
Summary page 4
…CERENOVUS Large Bore Medos International K193380 July 20, 2020 Catheter; CERENOVUS…
Codman & Shurtleff, Inc.2020—
†K173200SOFIA Plus Aspiration CatheterMicroVention, Inc.2018—

Also cleared against K193380: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250

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 22 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
  • 9 of the 27 ancestors have a recall of any class.
  • Of its descendants, K251828 (Cerenovus, Inc., 2025) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K193380.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · NRY

15in 2025

2007: 52008: 22009: 22010: 12011: 22012: 42014: 42015: 62016: 52017: 32018: 112019: 72020: 62021: 92022: 32023: 82024: 82025: 152026 (partial year): 14
2007high 15 (2025) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRY

129in 2025

2007: 94 days median2012: 90 days median2014: 140 days median2015: 128 days median2016: 75 days median2017: 185 days median2018: 156 days median2019: 89 days median2020: 125 days median2021: 80 days median2022: 129 days median2023: 112 days median2024: 165 days median2025: 129 days median2026 (partial year): 147 days median
2007high 185 (2017) · low 75 (2016)2026

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

Recalls per year · NRY

4in 2020

2010: 12013: 12017: 42020: 4, 4 Class I2026 (partial year): 2
2007high 4 (2017) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · NRY

565in 2025

2007: 132008: 182009: 572010: 2892011: 2632012: 3662013: 4052014: 4282015: 5982016: 4972017: 4322018: 4152019: 6502020: 7032021: 6882022: 5492023: 7112024: 6412025: 565
2007high 711 (2023) · low 13 (2007)2025

MAUDE reports naming product code NRY, 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
2007594013
20082—018
20092—057
20101—1289
20112—0263
20124900366
20130—1405
201441400428
201561280598
20165750497
201731854432
2018111560415
20197890650
202061254 (4)703
20219800688
202231290549
202381120711
202481650641
2025151290565
2026141472—

What is it indicated for?

CEREGLIDE™ 71 Intermediate Catheter The CEREGLIDE™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for…

Read the full statement (155 words)

CEREGLIDE™ 71 Intermediate Catheter

The CEREGLIDE™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Cerenovus Aspiration Tubing Set

The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter to the canister of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

Indications for use as stated in the FDA summary.

Also cleared against K193380

1 other device cites the same predicate.

  • K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2024

More from Cerenovus, Inc.

47 FDA decisions under this applicant name. See the company

  • P990040/S037TRUFILL n-BCA Liquid Embolic SystemCerenovus, Inc. · 2026
  • K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356)…Cerenovus, Inc. · 2026
  • P990040/S038TRUFILL n-BCA Liquid Embolic SystemCerenovus, Inc. · 2026
  • P990040/S034TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural SetCerenovus, Inc. · 2025
  • P990040/S036TRUFILL n-BCA Liquid Embolic SystemCerenovus, Inc. · 2025

Recent decisions in NRY

The NRY category page

  • K262021Toro 71 Aspiration Catheter; Toro Aspiration TubingToro Neurovascular, Inc. · 2026
  • K263266Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2026
  • K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc. · 2026
  • K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd. · 2026
  • K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc. · 2026

https://510kreport.com/device/K221934 · printed Nov 5, 2026

Cite this page

510(k) Report. “K221934: CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221934

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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