510(k) · Cleared
Recalled · 20118FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics Corp. · PDU Catheter For Crossing Total Occlusions
Cleared on Jun 29, 2007 as substantially equivalent to K971572 (Cordis Corp., 1997) and 2 other predicates after a 57-day review. Its family tree reaches back 2 generations to 1996. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 29, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- PDU
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961999 (1996). 5 ancestors in all. 21 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK961999 Schneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc. · 1996
- 1 generation backK980453 Schneider Guider Softip Guiding CathetersBoston Scientific Scimed, Inc. · 1998 · Recalled
- This deviceK071226 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063…Spectranetics Corp. · 2007
- Descendant · cites it directly · 20 of its ownK091299 Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009
- Descendant · 2 generations on · 19 of its ownK094036 Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010
- Descendant · 2 generations on · 17 of its ownK140775 Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · Recalled
- Descendant · 3 generations on · 8 of its ownK181642 B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018
- Descendant · 4 generations on · 6 of its ownK202835 Auryon Atherectomy SystemEximo Medical, Ltd. · 2020
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp. · 2009 · cites it directly20descendants
- K094036Turbo-Tandem System Model 472-110Spectranetics Corp. · 2010 · 2 generations on19descendants
- K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation · 2014 · 2 generations on17descendants
- K181642B-Laser Atherectomy SystemEximo Medical, Ltd. · 2018 · 3 generations on8descendants
- K202835Auryon Atherectomy SystemEximo Medical, Ltd. · 2020 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961999 | Schneider Guider Softip Guiding Catheters | Boston Scientific Scimed, Inc. | 1996 | — |
| −1 | K980453 | Schneider Guider Softip Guiding Catheters | Boston Scientific Scimed, Inc. | 1998 | 20 |
| 0 (this device) | K071226 | 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043 | Spectranetics Corp. | 2007 | — |
| +1 | K091299 | Spectranetics Turbo-Tandem System | Spectranetics Corp. | 2009 | — |
| +2 | K094036 | Turbo-Tandem System Model 472-110 | Spectranetics Corp. | 2010 | — |
| +2 | K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem System | Spectranetics Corporation | 2014 | 3 |
| +3 | K181642 | B-Laser Atherectomy System | Eximo Medical, Ltd. | 2018 | — |
| +4 | K202835 | Auryon Atherectomy System | Eximo Medical, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 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 |
|---|---|---|---|
| * | K971572 | Vista Brite Tip CathetersSummary page 1…ooster™ guiding catheters are substantially equivalent to many similar devices currently on the market. Spectranetics deems the Cordis Vista Brite Tip® Guiding Catheter (K971572) to be the primary predicate for the TURBO-Booster™. Additional predicates are the Scheidner Guider Softip® Guide Catheter (K9804… | 1997 |
| * | K980453 | Schneider Guider Softip Guiding CathetersSummary page 1…is Vista Brite Tip® Guiding Catheter (K971572) to be the primary predicate for the TURBO-Booster™. Additional predicates are the Scheidner Guider Softip® Guide Catheter (K980453) and the Boston Scientific Mach 1 Guiding Catheter (K020028). Ko71236 2 2of3 DEVICE DESCRIPTION The TURBO-Boost… | 1998 |
| * | K020028 | 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXXSummary page 1…mary predicate for the TURBO-Booster™. Additional predicates are the Scheidner Guider Softip® Guide Catheter (K980453) and the Boston Scientific Mach 1 Guiding Catheter (K020028). Ko71236 2 2of3 DEVICE DESCRIPTION The TURBO-Booster™ is comprised of a luer hub, strain relief, shaft, hydrop… | 2002 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091299 | Spectranetics Turbo-Tandem System | 2009 | 20 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2011 | Not classified | Z-2952-2011 | Package design/selection | Packaging integrity may be compromised, thus sterility can not be assured. |
| Jul 18, 2011 | Not classified | Z-2951-2011 | Package design/selection | Packaging integrity may be compromised, thus sterility can not be assured. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K091299 (Spectranetics Corp., 2009) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K971572.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Spectranetics TURBO-Booster™ guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
Not for use in the carotid and coronary 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/K071226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071226: 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071226
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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