Heartport Maze System: Cryoprobe Set
FDA 510(k) K970496 · Heartport, Inc.
510(k) numberK970496
Submission
- Device name
- Heartport Maze System: Cryoprobe Set
- Applicant
- Heartport, Inc.
Redwood City, CA, US - Received
- February 10, 1997
- Decision date
- May 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCL – Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
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|---|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)OCL · Special | AtriCure, Inc. | 07/24/2025SE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH)OCL · Traditional | AtriCure, Inc. | 08/27/2024SE |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | AtriCure, Inc. | 12/30/2022SE |
| K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…OCL · Special | Medtronic, Inc. | 12/22/2022SE |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEOCL · Traditional | AtriCure, Inc. | 07/26/2021SE |
| K211311 | AtriCure Isolator® Synergy Surgical Ablation SystemOCL · Special | AtriCure, Inc. | 05/28/2021SE |
| K200514 | Cardioblate Gemini-s Surgical Ablation DeviceOCL · Traditional | Medtronic | 06/03/2020SE |
| K193162 | EPi-Sense Guided Coagulation System with VisiTraxOCL · Special | AtriCure, Inc. | 12/13/2019SE |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenOCL · Special | AtriCure, Inc. | 11/04/2019SE |
| K191526 | Cardioblate CryoFlex Surgical Ablation SystemOCL · Special | Medtronic, Inc. | 10/01/2019SE |
More from Medtronic, Inc.
| 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 |
| K964302 | Heartport Thoracic TrocarDRC · Traditional | 05/09/1997SE |
| K964161 | Heartport Endoaortic ClampDXC · Traditional | 04/04/1997SE |
Questions and answers
When was Heartport Maze System: Cryoprobe Set cleared by the FDA?
Heartport Maze System: Cryoprobe Set (K970496) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 88 days after the submission was received.
What is the product code of K970496?
The FDA product code is OCL – Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, a Class II (moderate risk) device regulated under 21 CFR 878.4400.