510(k) Report

510(k) · Cleared

Cleared

CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer

K240004510(k) SpecialCleared Jan 31, 202429-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

Circa Scientific, Inc. · DYB Introducer, Catheter

Cleared on Jan 31, 2024 as substantially equivalent to K210185 (Talon Surgical, 2021) after a 29-day review. Its family tree reaches back 6 generations to 1997.

Decided
Jan 31, 2024
Review
29 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K964518 (1997). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2002: 1 other ancestor1998: 1 other ancestorK964518 · Fast-Cath Transseptal Catheter Introducer · Daig Corp. · 1997 · recalledK042623 · Agilis Steerable Catheter Introducer, Model 408304 · St. Jude Medical, Daig Division, Inc. · 2005 · recalledK061363 · Agilis NXT Steerable Introducer · St Jude Medical · 2006 · recalledK081645 · Agilis NXT Steerable Introducer, Model G408324 · St Jude Medical · 2008K110450 · Agilis NXT Steerable Introducer · St Jude Medical · 2011K210185 · CardioCurve Steerable Sheath · Talon Surgical · 20211995200020052010201520202025
Other ancestors, by generation 2 generations back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 1 other ancestor K210185 · CardioCurve Steerable Sheath · Talon Surgical · 2021K110450 · Agilis NXT Steerable Introducer · St Jude Medical · 2011K081645 · Agilis NXT Steerable Introducer, Model G408324 · St Jude Medical · 2008K061363 · Agilis NXT Steerable Introducer · St Jude Medical · 2006 · recalledK042623 · Agilis Steerable Catheter Introducer, Model 408304 · St. Jude Medical, Daig Division, Inc. · 2005 · recalledK964518 · Fast-Cath Transseptal Catheter Introducer · Daig Corp. · 1997 · recalled−50
  1. Root · 6 generations backK964518 Fast-Cath Transseptal Catheter IntroducerDaig Corp. · 1997 · Recalled
  2. 5 generations backK042623 Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc. · 2005 · Recalled
  3. 4 generations backK061363 Agilis NXT Steerable IntroducerSt Jude Medical · 2006 · Recalled
  4. 3 generations backK081645 Agilis NXT Steerable Introducer, Model G408324St Jude Medical · 2008
  5. 2 generations backK110450 Agilis NXT Steerable IntroducerSt Jude Medical · 2011
  6. 1 generation backK210185 CardioCurve Steerable SheathTalon Surgical · 2021
  7. This deviceK240004 CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S )…Circa Scientific, Inc. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K964518Fast-Cath Transseptal Catheter IntroducerDaig Corp.19974
−5K042623Agilis Steerable Catheter Introducer, Model 408304St. Jude Medical, Daig Division, Inc.20051
−4K061363Agilis NXT Steerable IntroducerSt Jude Medical20061
−3K081645Agilis NXT Steerable Introducer, Model G408324St Jude Medical2008—
−2K110450Agilis NXT Steerable IntroducerSt Jude Medical2011—
−1K210185CardioCurve Steerable SheathTalon Surgical2021—
0 (this device)K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve…Circa Scientific, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
201110
FIG. 1 — Lineage of K240004, 1997–2024Source: 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
*K210185CardioCurve Steerable Sheath
Summary page 5
…ry Class: II Product Code(s): DYB Regulation Number: 21 CFR 870.1340 Predicate Device: CardioCurve™ Steerable Sheath, K210185 3 Device Description The CardioCurve™ Steerable Sheath from CIRCA Scientific is an 8.5 Fr sterile, single-use catheter introdu…
Talon Surgical2021—

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 27 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
  • 4 of the 9 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. 2024, 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 CIRCA Scientific CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the heart through the interatrial septum.

Indications for use as stated in the FDA summary.

More from Circa Scientific, Inc.

6 FDA decisions under this applicant name. See the company

  • K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V…Circa Scientific, Inc. · 2025
  • K243954PeriCross™ Epicardial Access KitCirca Scientific, Inc. · 2025
  • K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc. · 2024
  • K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF…Circa Scientific, Inc. · 2024
  • K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, Inc. · 2023

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/K240004 · printed Nov 6, 2026

Cite this page

510(k) Report. “K240004: CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240004

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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