HEARTPORT ENDOAORTIC CLAMP— 510(k) K964161
Substantially EquivalentHeartport, Inc.
FDA 510(k) clearance K964161 for HEARTPORT ENDOAORTIC CLAMP, Substantially Equivalent on 1997-04-04. Applicant: Heartport, Inc.. Device class: 2.
Clearance details
- Applicant
- Heartport, Inc.
- Product code
- Code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
Recent devices under product code DXC
view all- K262086 — PreludeSYNC Radial Compression Device
- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K252772 — Arc Adjustable Radial Cuff Compression Device
- K254060 — Life Saving Tourniquet
- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
More 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 DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
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.