510(k) · Cleared
Recalled · 2009Scimed 6 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. · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 18, 1998 as substantially equivalent to K974684 (Scimed Life Systems, Inc., 1998) after a 90-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 18, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974684 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974684 Scimed 7 French Wiseguide Guide CatheterScimed Life Systems, Inc. · 1998 · Recalled
- This deviceK981788 Scimed 6 French Wiseguide Guide CatheterScimed Life Systems, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK092372 Heartrail Iii Guiding CatheterTerumo Corp. · 2009
- Descendant · 2 generations on · 0 of its ownK132556 Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK113335 Heartrail Iii Guiding CatheterTerumo Corporation · 2012
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 |
|---|---|---|---|---|---|
| −1 | K974684 | Scimed 7 French Wiseguide Guide Catheter | Scimed Life Systems, Inc. | 1998 | 3 |
| 0 (this device) | K981788 | Scimed 6 French Wiseguide Guide Catheter | Scimed Life Systems, Inc. | 1998 | — |
| +1 | K092372 | Heartrail Iii Guiding Catheter | Terumo Corp. | 2009 | — |
| +2 | K132556 | Sheathless Eaucath Coronary Guide Catheter | Asahi Intecc Co., Ltd. | 2013 | — |
| +2 | K113335 | Heartrail Iii Guiding Catheter | Terumo Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K974684 | Scimed 7 French Wiseguide Guide CatheterSummary page 2…use in the cerebral vasculature. Summary of Technological Characteristics: The 6 F Wiseguide catheter is similar to SCIMED's currently marketed 7 F Wiseguide catheter (K974684). Non-clinical Test Summary Functional testing consisted of pressure burst, tip bond tensile, shaft tensile, hub tensile, mater… | 1998 |
| * | — | 6 French Cyber Guide Catheters Named without a submission number | |
| * | — | Cordis® Corporation 6 French Vista Brite Tip™ Guide Catheters Named without a submission number |
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 |
|---|---|---|---|
| K092372 | Heartrail Iii Guiding Catheter | 2009 | 2 |
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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K092372 (Terumo Corp., 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
SCIMED 6 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/K981788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981788: Scimed 6 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/K981788
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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