HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE— 510(k) K961334
Substantially EquivalentHeartport, Inc.
FDA 510(k) clearance K961334 for HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE, Substantially Equivalent on 1996-11-15. Applicant: Heartport, Inc.. Device class: 2.
Clearance details
- Applicant
- Heartport, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
Recent devices under product code GEI
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
- K990772 — DIRECTFLOW ARTERIAL CANNULA
- K981009 — HEARTPORT ENDOPULMONARY VENT CATHETER
- K974736 — HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.