510(k) · Cleared
Recalled · 2005Amplatz Goose-Neck Snare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microvena Corp. · DXE Catheter, Embolectomy
Cleared on Dec 3, 1990 after a 249-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 48 devices in its family, counting itself, have a Class I recall. 47 later devices descend from it. It has been recalled once.
- Decided
- Dec 3, 1990
- Review
- 249 days
- Class
- Class II
- Product code
- DXE
- Recalls
- 1
- Predicates
- 0
47 later devices descend from it, 1 citing it directly. 4 of the 48 devices in this family, counting this one, have a Class I recall.
- This deviceK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990
- Descendant · cites it directly · 46 of its ownK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- Descendant · 2 generations on · 36 of its ownK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- Descendant · 3 generations on · 32 of its ownK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- Descendant · 2 generations on · 31 of its ownK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- Descendant · 3 generations on · 16 of its ownK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 47 · See all- K972511Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · cites it directly46descendants
- K021441Radius SnareRadius Medical Technologies, Inc. · 2002 · 2 generations on36descendants
- K022201Radius Micro SnareRadius Medical Technologies, Inc. · 2003 · 3 generations on32descendants
- K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003 · 2 generations on31descendants
- K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps · 2008 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | — |
| +1 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| +2 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| +3 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| +2 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| +3 | K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe Aps | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 1 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 1 |
| 2009 | 2 | 0 |
| 2010 | 2 | 1 |
| 2011 | 1 | 1 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
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.
4 devices in this family have a Class I recall. 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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? (47)
See all 471 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972511 | Amplatz Goose Neck Snare Kit/ Catheter | 1998 | 46 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2005 | Not classified | Z-0894-06 | Other | ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K972511 (Microvena Corp., 1998) has gone furthest, with 46 descendants of its own.
How does its category compare?
All DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | 0 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K901502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K901502: Amplatz Goose-Neck Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901502
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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