510(k) · Cleared
Recalled · 2008Acs Viking Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · DQY Catheter, Percutaneous
Cleared on Sep 26, 1997 as substantially equivalent to K953987 (Advanced Cardiovascular Systems, Inc., 1995) after an 86-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 26, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953987 (1995). 8 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK953987 Acs Tourgide Guiding CatheterAdvanced Cardiovascular Systems, Inc. · 1995
- This deviceK972484 Acs Viking Guiding CatheterGuidant Corp. · 1997
- Descendant · cites it directly · 3 of its ownK073289 Microsheath XL CathetersFlowcardia, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK131493 Sidekick and Usher Support CathetersC.R. Bard, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK161986 SIDEKICK and USHER Support CathetersBard Peripheral Vascular, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK091188 Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd. · 2010
- Descendant · 3 generations on · 0 of its ownK203275 Recon Support CatheterC.R. Bard, Inc. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K073289Microsheath XL CathetersFlowcardia, Inc. · 2008 · cites it directly3descendants
- K131493Sidekick and Usher Support CathetersC.R. Bard, Inc. · 2013 · 2 generations on2descendants
- K161986SIDEKICK and USHER Support CathetersBard Peripheral Vascular, Inc. · 2016 · 3 generations on1descendant
- K091188Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd. · 2010 · cites it directly1descendant
- K203275Recon Support CatheterC.R. Bard, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953987 | Acs Tourgide Guiding Catheter | Advanced Cardiovascular Systems, Inc. | 1995 | — |
| 0 (this device) | K972484 | Acs Viking Guiding Catheter | Guidant Corp. | 1997 | — |
| +1 | K073289 | Microsheath XL Catheters | Flowcardia, Inc. | 2008 | — |
| +2 | K131493 | Sidekick and Usher Support Catheters | C.R. Bard, Inc. | 2013 | — |
| +3 | K161986 | SIDEKICK and USHER Support Catheters | Bard Peripheral Vascular, Inc. | 2016 | — |
| +1 | K091188 | Asahi Zenyteex Guiding Catheter | Asahi Intecc Co., Ltd. | 2010 | — |
| +3 | K203275 | Recon Support Catheter | C.R. Bard, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 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? (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 |
|---|---|---|---|
| * | K953987 | Acs Tourgide Guiding CatheterSummary page 1…) Summary ACS VIKING™ Guiding Catheter . Device Name: ACS VIKING™ Guiding Catheter . Devices to which Equivalence is Claimed: ACS TOURGUIDE™ Coronary Guiding Catheter (K953987) . Indication: The ACS VIKING™ Guiding Catheter is intended to provide a pathway through which therapeutic and diagnostic device… | 1995 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2008 | Not classified | Z-1634-2008 | Labeling mix-ups | Mislabeling: The part number on the product label packaging may not match the product. |
| Mar 17, 2008 | Not classified | Z-1633-2008 | Labeling mix-ups | Mislabeling: The part number on the product label packaging may not match the product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ACS VIKING™ Guiding Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced.
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/K972484 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972484: Acs Viking Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972484
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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