510(k) · Cleared
ClearedCatapult Guide Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contract Medical International, GmbH · DYB Introducer, Catheter
Cleared on Aug 14, 2024 as substantially equivalent to K221914 (Contract Medical International, GmbH, 2022) after a 128-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- Aug 14, 2024
- Review
- 128 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K924607 (1993). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 5 generations between
- 3 generations backK142357 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015
- 2 generations backK181463 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018
- 1 generation backK221914 Catapult Guide SheathContract Medical International, GmbH · 2022
- This deviceK240957 Catapult Guide SheathContract Medical International, GmbH · 2024
- Descendant · cites it directly · 0 of its ownK250439 Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide…Contract Medical International, GmbH · 2025
Show all 9 generations
- Root · 9 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 8 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 7 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 6 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 5 generations backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- 4 generations backK100799 Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011
- 3 generations backK142357 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015
- 2 generations backK181463 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018
- 1 generation backK221914 Catapult Guide SheathContract Medical International, GmbH · 2022
- This deviceK240957 Catapult Guide SheathContract Medical International, GmbH · 2024
Most influential descendants
Showing 1 of 1 · See all- K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…Contract Medical International, GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −8 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −7 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −6 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −5 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| −4 | K100799 | Fortress Introducer Sheath System Model 358813, 358814, 358815 | Contract Medical Intl. GmbH | 2011 | — |
| −3 | K142357 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2015 | — |
| −2 | K181463 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2018 | — |
| −1 | K221914 | Catapult Guide Sheath | Contract Medical International, GmbH | 2022 | — |
| 0 (this device) | K240957 | Catapult Guide Sheath | Contract Medical International, GmbH | 2024 | — |
| +1 | K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F… | Contract Medical International, GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K221914 | Catapult Guide SheathSummary page 5…II Product Code: DYB, DRE 1.3 Predicate Device The predicate device is the Catapult TM Guide Sheath Introducer Sheath System (K221914). 1.4 Device Description The Catapult TM Guide Sheath consists of a coil reinforced introducer sheath with hemostasis valve and… | 2022 |
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 |
|---|---|---|---|
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm… | 2025 | 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 31 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K250439 (Contract Medical International, GmbH, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Catapult TM Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240957 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240957: Catapult Guide Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240957
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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