510(k) · Cleared
Recalled · 2009Scimed 7 French Wiseguide Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimed Life Systems, Inc. · DQY Catheter, Percutaneous
Cleared on Feb 19, 1998 after a 65-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 19, 1998
- Review
- 65 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 3
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK974684 Scimed 7 French Wiseguide Guide CatheterScimed Life Systems, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK981788 Scimed 6 French Wiseguide Guide CatheterScimed Life Systems, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 2 of its ownK092372 Heartrail Iii Guiding CatheterTerumo Corp. · 2009
- Descendant · 3 generations on · 0 of its ownK132556 Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK113335 Heartrail Iii Guiding CatheterTerumo Corporation · 2012
Most influential descendants
Showing 4 of 4 · See all- K981788Scimed 6 French Wiseguide Guide CatheterScimed Life Systems, Inc. · 1998 · cites it directly3descendants
- K092372Heartrail Iii Guiding CatheterTerumo Corp. · 2009 · 2 generations on2descendants
- K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd. · 2013 · 3 generations on0descendants
- K113335Heartrail Iii Guiding CatheterTerumo Corporation · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974684 | Scimed 7 French Wiseguide Guide Catheter | Scimed Life Systems, Inc. | 1998 | — |
| +1 | K981788 | Scimed 6 French Wiseguide Guide Catheter | Scimed Life Systems, Inc. | 1998 | 2 |
| +2 | K092372 | Heartrail Iii Guiding Catheter | Terumo Corp. | 2009 | — |
| +3 | K132556 | Sheathless Eaucath Coronary Guide Catheter | Asahi Intecc Co., Ltd. | 2013 | — |
| +3 | K113335 | Heartrail Iii Guiding Catheter | Terumo Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | SCIMED® 8 French Wiseguide™ Named without a submission number | |
| * | — | 7 French Triguide®-Max Guide Catheters Named without a submission number | |
| * | — | Cordis® Corporation 7 French Vista Brite Tip™ Guide Catheters Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981788 | Scimed 6 French Wiseguide Guide Catheter | 1998 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2009 | Not classified | Z-2013-2009 | Packaging | Boston Scientific is initiating a recall removal of numerous batches/lots of Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter. Boston Scientific has determined that the sterile… |
| Mar 11, 2009 | Not classified | Z-1470-2009 | Process change control | Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If there is difficulty making such… |
| May 22, 2006 | Not classified | Z-1102-06 | Other | Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981788 (Scimed Life Systems, Inc., 1998) has gone furthest, with 3 descendants of its own.
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?
SCIMED 7 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.
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/K974684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974684: Scimed 7 French Wiseguide Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974684
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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