DIRECTFLOW ARTERIAL CANNULA— 510(k) K990772
Substantially EquivalentHeartport, Inc.
FDA 510(k) clearance K990772 for DIRECTFLOW ARTERIAL CANNULA, Substantially Equivalent on 1999-03-23. Applicant: Heartport, Inc.. Device class: 2.
Clearance details
- Applicant
- Heartport, Inc.
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redwood City, CA, US
Recent devices under product code DWF
view allMore clearances from Heartport, Inc.
view all- K994243 — DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
- K981995 — QUICKDRAW VENOUS CANNULA
- K981009 — HEARTPORT ENDOPULMONARY VENT CATHETER
- K974736 — HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
- K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER
Adverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.