510(k) · Cleared
ClearedMicrosheath XL Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flowcardia, Inc. · DQY Catheter, Percutaneous
Cleared on Jan 11, 2008 as substantially equivalent to K051580 (Flowcardia, Inc., 2005) and 2 other predicates after a 51-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 11, 2008
- Review
- 51 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953987 (1995). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953987 Acs Tourgide Guiding CatheterAdvanced Cardiovascular Systems, Inc. · 1995
- 1 generation backK972484 Acs Viking Guiding CatheterGuidant Corp. · 1997 · Recalled
- This deviceK073289 Microsheath XL CathetersFlowcardia, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK131493 Sidekick and Usher Support CathetersC.R. Bard, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK161986 SIDEKICK and USHER Support CathetersBard Peripheral Vascular, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK203275 Recon Support CatheterC.R. Bard, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953987 | Acs Tourgide Guiding Catheter | Advanced Cardiovascular Systems, Inc. | 1995 | — |
| −1 | K972484 | Acs Viking Guiding Catheter | Guidant Corp. | 1997 | 2 |
| 0 (this device) | K073289 | Microsheath XL Catheters | Flowcardia, Inc. | 2008 | — |
| +1 | K131493 | Sidekick and Usher Support Catheters | C.R. Bard, Inc. | 2013 | — |
| +2 | K161986 | SIDEKICK and USHER Support Catheters | Bard Peripheral Vascular, Inc. | 2016 | — |
| +2 | K203275 | Recon Support Catheter | C.R. Bard, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K051580 | VP Sheath | 2005 |
| * | K972484 | Acs Viking Guiding CatheterSummary page 1…, 74 DQY / 21 CFR 870.1250 Predicate Devices The VP Sheath manufactured by FlowCardia, Inc. (KO51580) Viking 6Fr Guiding Catheters manufactured by Guidant (K972484) Zuma 6Fr Guiding Catheters manufactured by Mcdtronic (K981198) Device Description The FlowCardia MicroSheath TM XL… | 1997 |
| * | K981198 | Medtronic Zuma Guiding CatheterSummary page 1…h manufactured by FlowCardia, Inc. (KO51580) Viking 6Fr Guiding Catheters manufactured by Guidant (K972484) Zuma 6Fr Guiding Catheters manufactured by Mcdtronic (K981198) Device Description The FlowCardia MicroSheath TM XL is a single lumen catheter that is available in four lengths:… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131493 | Sidekick and Usher Support Catheters | 2013 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K131493 (C.R. Bard, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K051580.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The MicroSheath XL is a single lumen catheter intended to create a pathway for other devices in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073289: Microsheath XL Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073289
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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