510(k) · Cleared
ClearedCERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · NRY Catheter, Thrombus Retriever
Cleared on Jul 20, 2020 as substantially equivalent to K161064 (Penumbra, Inc., 2016) and 1 other predicate after a 228-day review. Its family tree reaches back 9 generations to 2001. 3 later devices descend from it.
- Decided
- Jul 20, 2020
- Review
- 228 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K003410 (2001). 26 ancestors in all, the oldest K003880 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 2 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 1 generation backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- This deviceK193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK221934 CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK251828 CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233988 Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 8 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 7 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 6 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 5 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 4 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 3 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
- 2 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
- 1 generation backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- This deviceK193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2023 · cites it directly1descendant
- K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2025 · 2 generations on0descendants
- K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −8 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −7 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −6 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −5 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −4 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −3 | K142458 | Penumbra System ACE | Penumbra, Inc. | 2015 | — |
| −2 | K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion Catheters | Penumbra, Inc. | 2016 | — |
| −1 | K161064 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016 | — |
| 0 (this device) | K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Codman & Shurtleff, Inc. | 2020 | — |
| +1 | K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2023 | — |
| +2 | K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2025 | — |
| +1 | K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161064 | Penumbra System ACE 68 Reperfusion CatheterSummary page 4…vice Name Manufacturer Number Penumbra System ACE 68 K161064 June 12, 2016 Penumbra, Inc. Re… | 2016 |
| * | K191237 | CERENOVUS Large Bore CatheterSummary page 4…anufacturer Number CERENOVUS Large Bore Medos International K191237 Nov 8, 2019 Catheter SARL… | 2019 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 9 of the 26 ancestors have a recall of any class.
- Of its descendants, K221934 (Cerenovus, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K161064.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NRY
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRY
129in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NRY
4in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · NRY
565in 2025
MAUDE reports naming product code NRY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 94 | 0 | 13 |
| 2008 | 2 | — | 0 | 18 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 289 |
| 2011 | 2 | — | 0 | 263 |
| 2012 | 4 | 90 | 0 | 366 |
| 2013 | 0 | — | 1 | 405 |
| 2014 | 4 | 140 | 0 | 428 |
| 2015 | 6 | 128 | 0 | 598 |
| 2016 | 5 | 75 | 0 | 497 |
| 2017 | 3 | 185 | 4 | 432 |
| 2018 | 11 | 156 | 0 | 415 |
| 2019 | 7 | 89 | 0 | 650 |
| 2020 | 6 | 125 | 4 (4) | 703 |
| 2021 | 9 | 80 | 0 | 688 |
| 2022 | 3 | 129 | 0 | 549 |
| 2023 | 8 | 112 | 0 | 711 |
| 2024 | 8 | 165 | 0 | 641 |
| 2025 | 15 | 129 | 0 | 565 |
| 2026 | 14 | 147 | 2 | — |
What is it indicated for?
The CERENOVUS Large Bore Catheter, with the CERENOVUS® Aspiration Tubing Set and NOUVAG Vacuson 60 aspiration pump (or equivalent 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 (120 words)
The CERENOVUS Large Bore Catheter, with the CERENOVUS® Aspiration Tubing Set and NOUVAG Vacuson 60 aspiration pump (or equivalent 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 failed IV t-PA are candidates for treatment.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193380: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193380
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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