510(k) Report

510(k) · Cleared

Cleared

Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca

K250439510(k) SpecialCleared Mar 16, 202530-day reviewClass II21 CFR 870.1340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Contract Medical International, GmbH · DYB Introducer, Catheter

Cleared on Mar 16, 2025 as substantially equivalent to K240957 (Contract Medical International, GmbH, 2024) after a 30-day review. Its family tree reaches back 10 generations to 1993.

Decided
Mar 16, 2025
Review
30 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K924607 (1993). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestorK924607 · Arrow Fischell Kink Resist Percut Sheath Intro Set · Arrow Intl., Inc. · 1993 · recalledK012812 · Carotid Guiding Sheath · Terumo Medical Corp. · 2001 · recalledK051601 · Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 2005K080415 · Device Modification to Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 2008K091329 · Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 2009 · recalledK100799 · Fortress Introducer Sheath System Model 358813, 358814, 358815 · Contract Medical Intl. GmbH · 2011K142357 · DuraSheath Introducer Sheath System · Contract Medical International, GmbH · 2015K181463 · DuraSheath Introducer Sheath System · Contract Medical International, GmbH · 2018K221914 · Catapult Guide Sheath · Contract Medical International, GmbH · 2022K240957 · Catapult Guide Sheath · Contract Medical International, GmbH · 20241990200020102020
Other ancestors, by generation 6 generations back: 1 other ancestor K240957 · Catapult Guide Sheath · Contract Medical International, GmbH · 2024K221914 · Catapult Guide Sheath · Contract Medical International, GmbH · 2022K181463 · DuraSheath Introducer Sheath System · Contract Medical International, GmbH · 2018K142357 · DuraSheath Introducer Sheath System · Contract Medical International, GmbH · 2015K100799 · Fortress Introducer Sheath System Model 358813, 358814, 358815 · Contract Medical Intl. GmbH · 2011K091329 · Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 2009 · recalledK080415 · Device Modification to Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 2008K051601 · Pinnacle Destination Peripheral Guiding Sheath · Terumo Medical Corp. · 2005K012812 · Carotid Guiding Sheath · Terumo Medical Corp. · 2001 · recalledK924607 · Arrow Fischell Kink Resist Percut Sheath Intro Set · Arrow Intl., Inc. · 1993 · recalled−10−50
  1. Root · 10 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
  2. 6 generations between
  3. 3 generations backK181463 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018
  4. 2 generations backK221914 Catapult Guide SheathContract Medical International, GmbH · 2022
  5. 1 generation backK240957 Catapult Guide SheathContract Medical International, GmbH · 2024
  6. This deviceK250439 Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide…Contract Medical International, GmbH · 2025
Show all 10 generations
  1. Root · 10 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
  2. 9 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
  3. 8 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
  4. 7 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
  5. 6 generations backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
  6. 5 generations backK100799 Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011
  7. 4 generations backK142357 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015
  8. 3 generations backK181463 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018
  9. 2 generations backK221914 Catapult Guide SheathContract Medical International, GmbH · 2022
  10. 1 generation backK240957 Catapult Guide SheathContract Medical International, GmbH · 2024
  11. This deviceK250439 Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide…Contract Medical International, GmbH · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K924607Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc.19933
−9K012812Carotid Guiding SheathTerumo Medical Corp.20011
−8K051601Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.2005—
−7K080415Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.2008—
−6K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp.20091
−5K100799Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH2011—
−4K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH2015—
−3K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH2018—
−2K221914Catapult Guide SheathContract Medical International, GmbH2022—
−1K240957Catapult Guide SheathContract Medical International, GmbH2024—
0 (this device)K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F…Contract Medical International, GmbH2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K250439, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K240957Catapult Guide Sheath
Summary page 5
…DYB, and DRE 1.3 Predicate Device The predicate device is the Catapult Guide Sheath Introducer Sheath System (K240957). 1.4 Device Description The Introducer Sheath System devices consist of a coil reinforced introducer sheath with hemostasis val…
Contract Medical International, GmbH2024—

What descends from it?

No later submission names this one as a predicate yet.

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 32 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
  • 3 of the 11 ancestors have a recall of any class.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.

The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.

Indications for use as stated in the FDA summary.

More from Contract Medical International, GmbH

7 FDA decisions under this applicant name. See the company

  • K240957Catapult Guide SheathContract Medical International, GmbH · 2024
  • K221914Catapult Guide SheathContract Medical International, GmbH · 2022
  • K203179Fortress Introducer Sheath SystemContract Medical International, GmbH · 2020
  • K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018
  • K153197Fortress Introducer Sheath SYstemContract Medical International, GmbH · 20161 recall

Recent decisions in DYB

The DYB category page

  • K262674Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K253526NAMIC Dilator and SheathMedline Industries, LP · 2026
  • K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit /…Hartman Medical Group, LLC · 2026
  • K261242SimplGuidePendracare · 2026
  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026

https://510kreport.com/device/K250439 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250439: Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250439

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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