510(k) · Cleared
Recalled · Class II · 2026Multi-Snare Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pfm Produkte Fur Die Medizin AG · DXE Catheter, Embolectomy
Cleared on Jan 24, 2002 as substantially equivalent to K925439 (Microvena Corp., 1993) and 1 other predicate after a 231-day review. Its family tree reaches back 1 generation to 1993. It has been recalled once.
- Decided
- Jan 24, 2002
- Review
- 231 days
- Class
- Class II
- Product code
- DXE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920823 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920823 Welter Snare RetrieverCook, Inc. · 1993
- This deviceK011783 Multi-Snare SetPfm Produkte Fur Die Medizin AG · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920823 | Welter Snare Retriever | Cook, Inc. | 1993 | — |
| 0 (this device) | K011783 | Multi-Snare Set | Pfm Produkte Fur Die Medizin AG | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 DXE? 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? (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 |
|---|---|---|---|
| * | K925439 | MicrosnareSummary page 1…e Name: Multi-Snare Set Common Name: Embolectomy Catheter Classification Name: Same Equivalent Devices: Manufacturer: Microvena Corporation Name: Microsnare 510(k) #: K925439 Manufacturer: Cook Inc. Name: Welter Snare Retriever 510(k) #: K920823 Device Description: The Multi-Snare Set is designed for… | 1993 |
| * | K920823 | Welter Snare RetrieverSummary page 1…Name: Same Equivalent Devices: Manufacturer: Microvena Corporation Name: Microsnare 510(k) #: K925439 Manufacturer: Cook Inc. Name: Welter Snare Retriever 510(k) #: K920823 Device Description: The Multi-Snare Set is designed for the following indications: e Retrieval and manipulation of foreign objec… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class II | Z-2526-2026 | Under Investigation by firm | A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K925439.
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 Multi-Snare Set (and its components) is intended for:
Retrieval and manipulation of foreign objects from
the vascular system and hollow viscera
Assistance in creating loops where cross-over
technique is applied
Repositioning of indwelling venous catheters
Assistance in performing venipuncture to obtain
access to central vein
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/K011783 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011783: Multi-Snare Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011783
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026