Heartport Endoaortic Clamp Catheter
FDA 510(k) K974175 · Heartport, Inc.
510(k) numberK974175
Submission
- Device name
- Heartport Endoaortic Clamp Catheter
- Applicant
- Heartport, Inc.
Redwood City, CA, US - Received
- November 6, 1997
- Decision date
- December 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWZ – Device, Biopsy, Endomyocardial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4075
- Specialty
- Cardiovascular
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More from Cordis Corp.
| 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 |
| 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 |
| K964161 | Heartport Endoaortic ClampDXC · Traditional | 04/04/1997SE |
Questions and answers
When was Heartport Endoaortic Clamp Catheter cleared by the FDA?
Heartport Endoaortic Clamp Catheter (K974175) received a 510(k) decision of Substantially Equivalent on December 16, 1997, 40 days after the submission was received.
What is the product code of K974175?
The FDA product code is DWZ – Device, Biopsy, Endomyocardial, a Class II (moderate risk) device regulated under 21 CFR 870.4075.