Cardioblate CryoFlex Surgical Ablation System
FDA 510(k) K191526 · Medtronic, Inc.
510(k) numberK191526
Submission
- Device name
- Cardioblate CryoFlex Surgical Ablation System
- Applicant
- Medtronic, Inc.
Minneapolis, MN, US - Received
- June 10, 2019
- Decision date
- October 1, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code OCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K190587 | Coolrail Linear PenOCL · Special | AtriCure, Inc. | 07/24/2019SE |
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| K262005 | Affera Integrated Mapping SystemDQK · Special | 08/21/2026SE |
| K261335 | VitalFlow Set with Balance BiosurfaceQJZ · Traditional | 07/31/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | 06/24/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | 05/28/2026SE |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial CannulaeDWF · Special | 04/23/2026SE |
| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | 02/19/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | 01/20/2026SE |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial…DTM · Special | 01/16/2026SE |
| K251831 | Bio-Medicus Life Support Catheter and IntroducerQHW · Traditional | 01/15/2026SE |
Questions and answers
When was Cardioblate CryoFlex Surgical Ablation System cleared by the FDA?
Cardioblate CryoFlex Surgical Ablation System (K191526) received a 510(k) decision of Substantially Equivalent on October 1, 2019, 113 days after the submission was received.
What is the product code of K191526?
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.