510(k) Report

FDA applicant

Heartport, Inc.

Redwood City, CA24 decisions1996–200016 recalls

FDA records 24 decisions for Heartport, Inc. (Redwood City, CA) from 1996 to 2000: 24 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DXC (Clamp, Vascular). Its devices cite 12 predicates, 7 of them its own earlier devices. 16 recalls are linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Heartport, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heartport, Inc. since 2007.

Recalls per year

1in 2019

2008: 22009: 22010: 12011: 12013: 22019: 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Heartport, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heartport, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass11decisions
  • DXCClamp, Vascular5decisions
  • DRCTrocar2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • DWZDevice, Biopsy, Endomyocardial1decision
  • GCJLaparoscope, General & Plastic Surgery1decision

Also: OCL (1), DYB (1), DSS (1).

Whose devices does it build on?

Its devices cite 12 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K970496Heartport Maze System: Cryoprobe SetHeartport, Inc. · 19976cite it
  • K974175Heartport Endoaortic Clamp CatheterHeartport, Inc. · 19973cite it
  • K955132Heartport Endoaortic ClampHeartport, Inc. · 19963cite it
  • K962510Heartport Endoaortic ClampHeartport, Inc. · 19962cite it
  • K961270Heartport Endosinus CatheterHeartport, Inc. · 19962cite it
  • K962366Heartport Cable Bulldog ClampHeartport, Inc. · 19961cites it

What has FDA decided for it lately?

  • 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
  • K974175Heartport Endoaortic Clamp CatheterHeartport, Inc. · 19972 recalls
  • K972570Heartport Introducer SheathHeartport, Inc. · 19975 recalls
  • K971291Heartport Endoarterial Return CannulaHeartport, Inc. · 19976 recalls

All 24 as Heartport, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K981995QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI…Nov 27, 2019Class II
  • K971291Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort…Jul 16, 2013Class II
  • K981995QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and…May 14, 2013Class II
  • K964248Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards…Jun 15, 2011
  • K964248EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO…Dec 3, 2010
  • K955132EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic…Sep 24, 2009