510(k) · Cleared
ClearedShuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DYB Introducer, Catheter
Cleared on Jul 24, 2015 as substantially equivalent to K091329 (Terumo Medical Corp., 2009) and 1 other predicate after a 298-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Jul 24, 2015
- Review
- 298 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924607 (1993). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 4 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 3 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 2 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 1 generation backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- This deviceK142819 Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer SetCook Incorporated · 2015
- Descendant · cites it directly · 0 of its ownK153430 Flexor Tuohy-Borst Side-Arm Introducers Shuttle SelectCook Incorporated · 2016
Most influential descendants
Showing 1 of 1 · See all- K153430Flexor Tuohy-Borst Side-Arm Introducers Shuttle SelectCook Incorporated · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −4 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −3 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −2 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −1 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| 0 (this device) | K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set | Cook Incorporated | 2015 | — |
| +1 | K153430 | Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select | Cook Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K091329 | Pinnacle Destination Peripheral Guiding SheathSummary page 4…The Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Set is substantially equivalent to the following devices: the Pinnacle® Destination® Peripheral Guiding Sheath (K091329) cleared on May 29, 2009 and the Cordis Brite Tip® Catheter Sheath Introducer (K984500) cleared on December 23, 1998. === Page 5… | 2009 |
| * | K984500 | Cordis Brite Tip Catheter Sheath Introducer SystemSummary page 4…nt to the following devices: the Pinnacle® Destination® Peripheral Guiding Sheath (K091329) cleared on May 29, 2009 and the Cordis Brite Tip® Catheter Sheath Introducer (K984500) cleared on December 23, 1998. Device Description: The Shuttle®-SL Flexor® Tuohy-Borst Side-Arm Introducer Set… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153430 | Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select | 2016 | 0 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K153430 (Cook Incorporated, 2016) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K091329.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142819: Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142819
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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