510(k) Report

510(k) · Cleared

Cleared

Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number Ecpb-a) Antegrade/Retrograde System

K962858510(k) TraditionalCleared Sep 30, 199670-day reviewClass II21 CFR 870.4450

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

Heartport, Inc. · DXC Clamp, Vascular

Cleared on Sep 30, 1996 as substantially equivalent to K955132 (Heartport, Inc., 1996) and 4 other predicates after a 70-day review. Its family tree reaches back 2 generations to 1981.

Decided
Sep 30, 1996
Review
70 days
Class
Class II
Product code
DXC
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K811411 (1981). 9 ancestors in all, the oldest K810360 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 3 other ancestors1988: 1 other ancestor1990: 1 other ancestor1985: 1 other ancestor1981: 1 other ancestorK811411 · Swan-Ganz Heparin Coated, Etc. Catheter · American Edwards Laboratories · 1981K961245 · Heartport Endopulmonary Vent · Heartport, Inc. · 19961980198519901995
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors K961245 · Heartport Endopulmonary Vent · Heartport, Inc. · 1996K811411 · Swan-Ganz Heparin Coated, Etc. Catheter · American Edwards Laboratories · 19810
  1. Root · 2 generations backK811411 Swan-Ganz Heparin Coated, Etc. CatheterAmerican Edwards Laboratories · 1981
  2. 1 generation backK961245 Heartport Endopulmonary VentHeartport, Inc. · 1996
  3. This deviceK962858 Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem…Heartport, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K811411Swan-Ganz Heparin Coated, Etc. CatheterAmerican Edwards Laboratories1981—
−1K961245Heartport Endopulmonary VentHeartport, Inc.1996—
0 (this device)K962858Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog…Heartport, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198510
198810
199010
199630
FIG. 1 — Lineage of K962858, 1981–1996Source: 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 DXC? 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 DXC device

  1. #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 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? (5)

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
*K955132Heartport Endoaortic Clamp
Summary page 1
…ular Antegrade Cardiopulmonary Bypass System is composed of the following commercially available bypass catheters, cannulae and accessories: Heartport Endoaortic Clamp (K955132) Heartport Endopulmonary Vent (K961245) Heartport Endoarterial Return Cannula (K955121) Medtronic DLP Venous Drainage Cannula…
Heartport, Inc.19962
*K961245Heartport Endopulmonary Vent
Summary page 1
…stem is composed of the following commercially available bypass catheters, cannulae and accessories: Heartport Endoaortic Clamp (K955132) Heartport Endopulmonary Vent (K961245) Heartport Endoarterial Return Cannula (K955121) Medtronic DLP Venous Drainage Cannula (K875353) or a substantially equivalent…
Heartport, Inc.1996—
*K955121Heartport Endoarterial Return Cannual
Summary page 1
…ailable bypass catheters, cannulae and accessories: Heartport Endoaortic Clamp (K955132) Heartport Endopulmonary Vent (K961245) Heartport Endoarterial Return Cannula (K955121) Medtronic DLP Venous Drainage Cannula (K875353) or a substantially equivalent Heartport manufactured device The Heartport Endo…
Heartport, Inc.19965
*K875353Percutaneous Arterial/Venous Cannula Placement Kit
Summary page 1
…s: Heartport Endoaortic Clamp (K955132) Heartport Endopulmonary Vent (K961245) Heartport Endoarterial Return Cannula (K955121) Medtronic DLP Venous Drainage Cannula (K875353) or a substantially equivalent Heartport manufactured device The Heartport Endovascular Antegrade/Retrograde Cardiopulmonary Byp…
Dlp, Inc.19881
*K961270Heartport Endosinus Catheter
Summary page 1
…device The Heartport Endovascular Antegrade/Retrograde Cardiopulmonary Bypass System consists of the above Antegrade Kit in addition to: Heartport Endosinus Catheter (K961270) Heartport, Inc. CONFIDENTIAL 10 Endovascular Cardiopulmonary Bypass Systems Appendices Intended Use: The Hear…
Heartport, Inc.1996—

Also cleared against K955132: 2 other devices →

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 15 years and passes through 2 companies; a new generation was cleared every 15.0 years on median.
  • 3 of the 9 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K955132.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXC

2in 2025

2007: 102008: 32009: 42010: 22011: 62012: 52013: 142014: 42015: 52016: 32017: 32018: 22019: 22020: 32021: 62022: 12023: 42024: 12025: 22026 (partial year): 4
2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007: 52 days median2008: 29 days median2009: 83 days median2011: 51 days median2012: 73 days median2013: 89 days median2014: 157 days median2015: 71 days median2016: 91 days median2017: 90 days median2020: 209 days median2021: 37 days median2023: 215 days median2026 (partial year): 125 days median
2007high 215 (2023) · low 29 (2008)2026

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

Recalls per year · DXC

2in 2023

2008: 22009: 22010: 12011: 32014: 12022: 12023: 2
2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXC

442in 2025

2007: 2982008: 3022009: 5392010: 6002011: 6912012: 5482013: 9202014: 4942015: 3742016: 4942017: 4162018: 3912019: 3932020: 4042021: 3712022: 2732023: 6742024: 3752025: 442
2007high 920 (2013) · low 273 (2022)2025

MAUDE reports naming product code DXC, 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
200710520298
20083292302
20094832539
20102—1600
20116513691
20125730548
201314890920
201441571494
20155710374
20163910494
20173900416
20182—0391
20192—0393
202032090404
20216370371
20221—1273
202342152674
20241—0375
20252—0442
202641250—

What is it indicated for?

The Heartport Endovascular Cardiopulmonary Bypass Systems are indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart. The system consists of a set of catheters, cannulae and accessories that permits a patient to be maintained on cardiopulmonary bypass and the patient’s heart to be arrested without the need for a median sternotomy.

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 K955132

2 other devices cite the same predicate.

  • K033085PortaclampCardio Life Research, S.A. · 2004
  • K964161Heartport Endoaortic ClampHeartport, Inc. · 19974 recalls

More from Heartport, Inc.

24 FDA decisions under this applicant name. See the company

  • K994243Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip, Straightshot Kit, 23 FR…Heartport, Inc. · 2000
  • K981995Quickdraw Venous CannulaHeartport, Inc. · 19992 recalls
  • K990772Directflow Arterial CannulaHeartport, Inc. · 19996 recalls
  • K981009Heartport Endopulmonary Vent CatheterHeartport, Inc. · 1998
  • K974736Heartport Direct Aortic Return Cannula with IntroducerHeartport, Inc. · 19985 recalls

Recent decisions in DXC

The DXC category page

  • K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026
  • K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences · 2026
  • K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc. · 2026
  • K254060Life Saving TourniquetTW Medical · 2026
  • K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLC · 2025

https://510kreport.com/device/K962858 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962858: Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number Ecpb-a) Antegrade/Retrograde System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962858

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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