510(k) · Cleared
Recalled · 2007Amplatz Goose Neck Snare Kit/ Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microvena Corp. · DXE Catheter, Embolectomy
Cleared on Mar 6, 1998 as substantially equivalent to K901502 (Microvena Corp., 1990) after a 246-day review. Its family tree reaches back 1 generation to 1990. 4 of the 48 devices in its family, counting itself, have a Class I recall. 46 later devices descend from it. It has been recalled once.
- Decided
- Mar 6, 1998
- Review
- 246 days
- Class
- Class II
- Product code
- DXE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901502 (1990). 46 later devices descend from it, 7 citing it directly. 4 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- This deviceK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998
- Descendant · cites it directly · 36 of its ownK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- Descendant · 2 generations on · 32 of its ownK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- Descendant · cites it directly · 31 of its ownK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- Descendant · 2 generations on · 16 of its ownK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
- Descendant · cites it directly · 11 of its ownK021606 EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc. · 2002
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 46 · See all- K021441Radius SnareRadius Medical Technologies, Inc. · 2002 · cites it directly36descendants
- K022201Radius Micro SnareRadius Medical Technologies, Inc. · 2003 · 2 generations on32descendants
- K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003 · cites it directly31descendants
- K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps · 2008 · 2 generations on16descendants
- K021606EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc. · 2002 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| 0 (this device) | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | — |
| +1 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| +2 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| +1 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| +2 | K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe Aps | 2008 | — |
| +1 | K021606 | EN-Snare Endovascular Snare and Catheter | Medical Device Technologies, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K901502 | Amplatz Goose-Neck SnareSummary page 1…te January 13, 1998 The Amplatz Goose Neck Snare Intravascular Retrieval Device Percutaneous Retrieval Device MICROVENA Amplatz Goose Neck Snare Premarket Notification K901502 The Amplatz Goose Neck Snare consists of a braided nitinol loop attached to a solid core nitinol guidewire. The plane of the l… | 1990 |
What descends from it? (46)
See all 467 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021441 | Radius Snare | 2002 | 36 |
| K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | 2003 | 31 |
| K021606 | EN-Snare Endovascular Snare and Catheter | 2002 | 11 |
| K122088 | Merit One Snare System | 2012 | 2 |
| K241259 | Amplatz Goose Neck Snare Kit | 2024 | 0 |
| K200268 | Halo™ Single-Loop Snare Kit | 2020 | 0 |
| K102484 | Sequre Snare System | 2010 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2007 | Not classified | Z-0992-2007 | Other | Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr. |
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 · 2 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 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K021441 (Radius Medical Technologies, Inc., 2002) has gone furthest, with 36 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 | — |
What is it indicated for?
The Amplatz Goose Neck Snare is a Class II device intended
for use in the cardiovascular system or hollow viscous to
retrieve and manipulate foreign objects. Manipulation
procedures include indwelling venous catheter repositioning,
indwelling venous catheter fibrin sheath stripping, and central
venous access venipuncture procedure assistance.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972511: Amplatz Goose Neck Snare Kit/ Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972511
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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