Heartport Endoaortic Clamp
FDA 510(k) K964161 · Heartport, Inc.
510(k) numberK964161
Submission
- Device name
- Heartport Endoaortic Clamp
- Applicant
- Heartport, Inc.
Redwood City, CA, US - Received
- October 17, 1996
- Decision date
- April 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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More from Vascular Graft Solutions, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K994243 | Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip…DWF · Special | 05/05/2000SE |
| K981995 | Quickdraw Venous CannulaDWF · Traditional | 04/20/1999SE |
| K990772 | Directflow Arterial CannulaDWF · Special | 03/23/1999SE |
| K981009 | Heartport Endopulmonary Vent CatheterDWF · Traditional | 09/04/1998SE |
| K974736 | Heartport Direct Aortic Return Cannula with IntroducerDWF · Traditional | 07/15/1998SE |
| K974175 | Heartport Endoaortic Clamp CatheterDWZ · Traditional | 12/16/1997SE |
| K972570 | Heartport Introducer SheathDYB · Traditional | 10/01/1997SE |
| K971291 | Heartport Endoarterial Return CannulaDWF · Traditional | 06/17/1997SE |
| K970496 | Heartport Maze System: Cryoprobe SetOCL · Traditional | 05/09/1997SE |
| K964302 | Heartport Thoracic TrocarDRC · Traditional | 05/09/1997SE |
Questions and answers
When was Heartport Endoaortic Clamp cleared by the FDA?
Heartport Endoaortic Clamp (K964161) received a 510(k) decision of Substantially Equivalent on April 4, 1997, 169 days after the submission was received.
What is the product code of K964161?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.