510(k) · Cleared
ClearedGandras Intravascular Catheter, Models 5580, 5581 and 5582
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Feb 1, 2008 as substantially equivalent to K023681 (Boston Scientific Corp, 2002) and 2 other predicates after an 80-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Feb 1, 2008
- Review
- 80 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K020012 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK020012 Modification to Renegade Fiber Braided MicrocatheterBoston Scientific/Medi-Tech · 2002 · Recalled
- This deviceK073200 Gandras Intravascular Catheter, Models 5580, 5581 and 5582Vascular Solutions, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020012 | Modification to Renegade Fiber Braided Microcatheter | Boston Scientific/Medi-Tech | 2002 | 1 |
| 0 (this device) | K073200 | Gandras Intravascular Catheter, Models 5580, 5581 and 5582 | Vascular Solutions, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K023681 | Renegade STC 18 MicrocatheterSummary page 1…sification Name: Diagnostic intravascular catheter (21 CFR 870.1200, Product Code DQO) Predicate Devices Renegade STCTM 18 Microcatheter (K023681, K020012), manufactured by Boston Scientific Corporation. AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coate… | 2002 |
| * | K020012 | Modification to Renegade Fiber Braided MicrocatheterSummary page 1…n Name: Diagnostic intravascular catheter (21 CFR 870.1200, Product Code DQO) Predicate Devices Renegade STCTM 18 Microcatheter (K023681, K020012), manufactured by Boston Scientific Corporation. AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Cathete… | 2002 |
| * | K061733 | Angiodynamics Soft-VU and Mariner Hydrophilic Coated Angiographic CatheterSummary page 1…8 Microcatheter (K023681, K020012), manufactured by Boston Scientific Corporation. AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Catheters (K061733), manufactured by AngioDynamics, Inc. Device Description The Gandras catheter is an angiographic intravascular catheter that has… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 3 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K023681.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Gandras catheter is designed to be used for delivering embolic materials and
radiopaque media to selected sites in the vascular system. Diagnostic, embolic, or
therapeutic agents are to be used in accordance with specifications outlined by the
manufacturer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073200 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073200: Gandras Intravascular Catheter, Models 5580, 5581 and 5582.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073200
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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