DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP— 510(k) K994243

Clearance details

Applicant

Heartport, Inc.

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

1999-12-16

Decision date

2000-05-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Redwood City, CA, US

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• K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
• K253671 — Dual Stage Venous Cannulae2026-01-30

• K981995 — QUICKDRAW VENOUS CANNULA1999-04-20
• K990772 — DIRECTFLOW ARTERIAL CANNULA1999-03-23
• K981009 — HEARTPORT ENDOPULMONARY VENT CATHETER1998-09-04
• K974736 — HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER1998-07-15
• K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER1997-12-16

Death

106

Injury

386

Malfunction

2,323

Total

2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →