510(k) · Cleared
ClearedSchneider Guider Softip Guiding Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · DYG Catheter, Flow Directed
Cleared on Nov 19, 1996 after a 181-day review. The FDA summary names its predicate without a number. 28 later devices descend from it.
- Decided
- Nov 19, 1996
- Review
- 181 days
- Class
- Class II
- Product code
- DYG
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly.
- This deviceK961999 Schneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc. · 1996
- Descendant · cites it directly · 26 of its ownK980453 Schneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 21 of its ownK071226 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063…Spectranetics Corp. · 2007 · Recalled
- Descendant · 3 generations on · 20 of its ownK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- Descendant · 4 generations on · 19 of its ownK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- Descendant · 4 generations on · 17 of its ownK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K980453Schneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc. · 1998 · cites it directly26descendants
- K0712268FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043Spectranetics Corp. · 2007 · 2 generations on21descendants
- K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009 · 3 generations on20descendants
- K094036Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010 · 4 generations on19descendants
- K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961999 | Schneider Guider Softip Guiding Catheters | Boston Scientific Scimed, Inc. | 1996 | — |
| +1 | K980453 | Schneider Guider Softip Guiding Catheters | Boston Scientific Scimed, Inc. | 1998 | 20 |
| +2 | K071226 | 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043 | Spectranetics Corp. | 2007 | 2 |
| +3 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| +4 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
| +4 | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem System | Spectranetics Corporation | 2014 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 DYG? 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 DYG device
- #1 K242451 HemoSphere Alta Advanced Monitoring Platform…score 24.2 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Petite brite tip® guiding catheter (6 FR) Named without a submission number | |
| * | — | Vista brite tip™ guiding catheter (10 FR) Named without a submission number | |
| * | — | TRIGUIDE® guiding catheter (10 FR) Named without a submission number | |
| * | — | DVI guiding catheter (10 FR) Named without a submission number | |
| * | — | SOLID-7 guiding catheter (packaging only) Named without a submission number |
What descends from it? (28)
See all 282 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K980453 (Boston Scientific Scimed, Inc., 1998) has gone furthest, with 26 descendants of its own.
How does its category compare?
All DYG devicesDYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYG
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DYG
188in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYG
2in 2019
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DYG
268in 2025
MAUDE reports naming product code DYG, 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 | 0 | — | 1 | 168 |
| 2008 | 1 | — | 0 | 400 |
| 2009 | 0 | — | 3 | 145 |
| 2010 | 0 | — | 0 | 147 |
| 2011 | 1 | — | 0 | 249 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 149 |
| 2014 | 0 | — | 0 | 178 |
| 2015 | 0 | — | 0 | 163 |
| 2016 | 1 | — | 0 | 154 |
| 2017 | 0 | — | 0 | 115 |
| 2018 | 0 | — | 4 (4) | 133 |
| 2019 | 0 | — | 2 | 144 |
| 2020 | 1 | — | 0 | 104 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 0 | 130 |
| 2023 | 1 | — | 0 | 229 |
| 2024 | 3 | 188 | 0 | 226 |
| 2025 | 0 | — | 0 | 268 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The SCHNEIDER GUIDER Softip® guiding catheter is designed for the intravascular introduction of interventional devices.
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/K961999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961999: Schneider Guider Softip Guiding Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961999
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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