510(k) K053436
- Device
- SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
- Applicant
- CRYOCATH TECHNOLOGIES, INC.
- 510(k) number
- K053436
- Product code
- OCL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-01-13
- Date received
- 2005-12-09
- Regulation
- 878.4400
- Classification name
- Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
- Medical specialty
- General & Plastic Surgery
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRED MILDER
- Address
- 204 Clinton Rd. Brookline MA US 02445 02445
FDA Registration Numbers#
- 1721676
- 2954783
- 2184009
- 3008262715
- 3011706110
- 2134265
- 3026612481
- 1047843
- 2087259
- 1717344
- 1423662
- 1928237
- 3009882464
- 1036836
- 2028523
- 1319639
- 2528981
- 3008592544
- 3008729892
- 9616793
- 3035387162
- 2133810
- 3018094310
- 1721983
- 3003955307
- 2182291
- 9616065
- 2124215
- 9611854
- 3005012805
Source Documents#
Other 510(k) Records For Product Code OCL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252056 | Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. | 2025-07-24 |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH) | AtriCure, Inc. | 2024-08-27 |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) | AtriCure, Inc. | 2022-12-30 |
| K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | Medtronic, Inc. | 2022-12-22 |
| K210477 | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE | AtriCure, Inc. | 2021-07-26 |
| K211311 | AtriCure Isolator® Synergy™ Surgical Ablation System | AtriCure, Inc. | 2021-05-28 |
| K200514 | Cardioblate Gemini-s Surgical Ablation Device | Medtronic | 2020-06-03 |
| K193162 | EPi-Sense Guided Coagulation System with VisiTrax | AtriCure, Inc. | 2019-12-13 |
| K192125 | Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen | AtriCure, Inc. | 2019-11-04 |
| K191526 | Cardioblate CryoFlex Surgical Ablation System | Medtronic, Inc. | 2019-10-01 |
| K190587 | Coolrail Linear Pen | AtriCure, Inc. | 2019-07-24 |
| K190623 | Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device | Medtronic | 2019-05-30 |
| K190151 | COBRA Fusion Ablation System | AtriCure, Inc. | 2019-02-25 |
| K182610 | Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device | Medtronic | 2018-12-19 |
| K183065 | Coolrail Linear Pen | AtriCure, Inc. | 2018-12-04 |
Legacy Summary#
summary
FDA Review#
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