510(k) Report

510(k) · Cleared

Cleared

Datascope's 10 FR. Flexisheath Percutaneous Introducer

K973007510(k) TraditionalCleared Nov 6, 199785-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

Datascope Corp. · DYB Introducer, Catheter

Cleared on Nov 6, 1997 as substantially equivalent to K820834 (Datascope Corp., 1982) and 7 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1979.

Decided
Nov 6, 1997
Review
85 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K790775 (1979). 13 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 4 other ancestors1994: 2 other ancestors1993: 2 other ancestors1991: 1 other ancestor1982: 1 other ancestor1996: 1 other ancestorK790775 · Intra-Aortic Balloon, Type S · Datascope Corp. · 1979K964987 · Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0 · Datascope Corp. · 1997 · recalled19751980198519901995
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 4 other ancestors K964987 · Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0 · Datascope Corp. · 1997 · recalledK790775 · Intra-Aortic Balloon, Type S · Datascope Corp. · 19790
  1. Root · 2 generations backK790775 Intra-Aortic Balloon, Type SDatascope Corp. · 1979
  2. 1 generation backK964987 Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon…Datascope Corp. · 1997 · Recalled
  3. This deviceK973007 Datascope's 10 FR. Flexisheath Percutaneous IntroducerDatascope Corp. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K790775Intra-Aortic Balloon, Type SDatascope Corp.1979—
−1K964987Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for…Datascope Corp.19971
0 (this device)K973007Datascope's 10 FR. Flexisheath Percutaneous IntroducerDatascope Corp.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
199110
199320
199420
199540
199610
FIG. 1 — Lineage of K973007, 1979–1997Source: 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
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What was it cleared against? (8)

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
*K820834Percor Percutaneous Introducer
Summary page 1
…fied under 21 CFR 870.1340 PREDICATE DEVICE INFORMATION Datascope’s FlexiSheath Percutaneous Introducer is substantially equivalent to the following marketed devices: K820834 - Datascope’s 10 Fr. Percor Percutaneous Introducer with Hemostasis Valve K902674 - Datascope’s Arterial cannula with Access Por…
Datascope Corp.1982—
*K902674Datascope Arterial Cannula W/Access Port
Summary page 1
…ercutaneous Introducer is substantially equivalent to the following marketed devices: K820834 - Datascope’s 10 Fr. Percor Percutaneous Introducer with Hemostasis Valve K902674 - Datascope’s Arterial cannula with Access Port K924607 - Super Arrow-Flex Percutaneous Sheath Introducer (Arrow Fischell Corp.)…
Datascope Corp.1991—
*K924607Arrow Fischell Kink Resist Percut Sheath Intro Set
Summary page 1
…following marketed devices: K820834 - Datascope’s 10 Fr. Percor Percutaneous Introducer with Hemostasis Valve K902674 - Datascope’s Arterial cannula with Access Port K924607 - Super Arrow-Flex Percutaneous Sheath Introducer (Arrow Fischell Corp.) K940092 - Bard’s Input Percutaneous Arterial/Venous Cat…
Arrow Intl., Inc.19933
*K940092Usci Input Introducer Set
Summary page 1
…roducer with Hemostasis Valve K902674 - Datascope’s Arterial cannula with Access Port K924607 - Super Arrow-Flex Percutaneous Sheath Introducer (Arrow Fischell Corp.) K940092 - Bard’s Input Percutaneous Arterial/Venous Catheter Introducer Page 23 Summary of Safety & Effectiveness/Datasc…
Usci, Div. C.R. Bard, Inc.1995—
*K940178Percor Stat-DL 9.5 FR.34CC & 40CC /Percor Stat-DL 10.5 FR.40CC & 50CC Intra-Aortic…
Summary page 2
…put Percutaneous Arterial/Venous Catheter Introducer Page 23 Summary of Safety & Effectiveness/Datascope’s 10 Fr. FlexiSheath ™ Percutaneous Introducer K940178 - Datascope’s Percor STAT-DL 9.5 Fr. 34cc and 40cc & 10.5 Fr. 40cc and 50cc IABs with Alternate Inner Lumen K940231 - Datascope’…
Datascope Corp.1994—
*K940231Intra-Aortic Balloon for Optional Sheathless Insertion
Summary page 2
…cope’s 10 Fr. FlexiSheath ™ Percutaneous Introducer K940178 - Datascope’s Percor STAT-DL 9.5 Fr. 34cc and 40cc & 10.5 Fr. 40cc and 50cc IABs with Alternate Inner Lumen K940231 - Datascope’s Percor STAT-DL 40cc IAB with Alternate Membrane Material K943896 - Datascope’s Staged Guide Wire for use with Data…
Datascope Corp.1994—
*K943896Guide Wire for the Use with Datascope Percor Stat-DL Iabs
Summary page 2
…r STAT-DL 9.5 Fr. 34cc and 40cc & 10.5 Fr. 40cc and 50cc IABs with Alternate Inner Lumen K940231 - Datascope’s Percor STAT-DL 40cc IAB with Alternate Membrane Material K943896 - Datascope’s Staged Guide Wire for use with Datascope’s Percor STAT-IABs. K964987 - Datascope’s Percor STAT-DL 9.5 Fr. 25 and 4…
Datascope Corp.1995—
*K964987Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional…
Summary page 2
…umen K940231 - Datascope’s Percor STAT-DL 40cc IAB with Alternate Membrane Material K943896 - Datascope’s Staged Guide Wire for use with Datascope’s Percor STAT-IABs. K964987 - Datascope’s Percor STAT-DL 9.5 Fr. 25 and 40cc IAB. DEVICE DESCRIPTION/INTENDED USE Datascope’s 10 Fr. FlexiSheath™ Percutane…
Datascope Corp.19971

Also cleared against K820834: 1 other device →

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 18 years and passes through 1 company; a new generation was cleared every 17.5 years on median.
  • 2 of the 13 ancestors have a recall of any class.
  • 1 other device also cites its predicate K820834.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Datascope’s 10 Fr. FlexiSheath™ Percutaneous Introducer is intended for the percutaneous introduction of Datascope’s 9.5Fr. Intra-Aortic Balloon Catheters.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K820834

1 other device cites the same predicate.

  • K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with…Datascope Corp. · 1998

More from Datascope Corp.

149 FDA decisions under this applicant name. See the company

  • K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp. · 2019
  • K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 201827 Class I recalls
  • K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp. · 20172 recalls
  • K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 20177 Class I recalls
  • K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 201512 Class I recalls

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/K973007 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973007: Datascope's 10 FR. Flexisheath Percutaneous Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973007

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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