Heartport Needle Trocar
FDA 510(k) K965051 · Heartport, Inc.
510(k) numberK965051
Submission
- Device name
- Heartport Needle Trocar
- Applicant
- Heartport, Inc.
Redwood City, CA, US - Received
- December 18, 1996
- Decision date
- March 12, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
Other 510(k)s with product code DRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230)DRC · Traditional | Synaptic Medical Corporation | 07/26/2024SE |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)DRC · Special | Pressure Products Medical Device Manufacturing… | 05/17/2024SE |
| K221707 | SafeSept® Transseptal Guidewire (SS-140)DRC · Special | Pressure Products Medical Device Manufacturing… | 09/14/2022SE |
| K212625 | PathBuilder Transseptal NeedleDRC · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 03/23/2022SE |
| K210328 | SafeSept Blunt NeedleDRC · Special | Pressure Products Medical Device Manufacturing… | 03/05/2021SE |
| K172950 | TSN Transseptal NeedleDRC · Traditional | Pressure Products Medical Device Manufacturing… | 02/21/2018SE |
| K172934 | Needle Free Transseptal CannulaDRC · Traditional | Pressure Products Medical Device Manufacturing… | 02/16/2018SE |
| K172893 | SafeSept Needle Free Transseptal GuidewireDRC · Traditional | Pressure Products Medical Device Manufacturing… | 12/21/2017SE |
| K170671 | SafeSept Transseptal GuidewireDRC · Traditional | Pressure Products Medical Device Manufacturing… | 10/20/2017SE |
| K132943 | Intracardic Catheter Introducer Kit and Transseptal NeedleDRC · Traditional | Synaptic Medical Limited | 08/29/2014SE |
More from Synaptic Medical Limited
| 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 Needle Trocar cleared by the FDA?
Heartport Needle Trocar (K965051) received a 510(k) decision of Substantially Equivalent on March 12, 1997, 84 days after the submission was received.
What is the product code of K965051?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.