Cryocath Technologies, Inc.
Country not established
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Cryocath Technologies, Inc. makes
Cryocath Technologies, Inc. manufactures cryosurgical devices and consoles for cardiac ablation procedures, including the SurgiFrost XL and SurgiFrost cryoprobes (6 cm, 7 cm, and 10 cm), the Freezor Xtra surgical cardiac cryoablation device, and associated cryoconsoles. Their portfolio also includes steerable sheaths and dilators, such as the FlexCath, designed for precise catheter navigation during cryoablation. The company produces both standalone cryoprobes and bundled systems combining probes, clamps, and consoles for integrated use.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- 510(k) 510(k)
Surgifrost 6cm, 7cm And 10 Cm Cryosurgical Devices Plus Frostbyte Clamp And Cryosurgical Console Ref K053436
510(k) 510(k)- 510(k) 510(k)
Freezor Xtra Surgical Cardiac Cryoablation Device And CCT.2 Cardiac Cardiac Cryoablation Cryoconsole Ref K030303
510(k) 510(k)Flexcath Steerable Sheath & Dilator Ref K070357
510(k) 510(k)- 510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Cryocath Technologies, Inc., initiated on 2006-08-04. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 4 Aug 2006 Z-1452-06 Unclassified (pre-2012) Terminated Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.
Frequently asked questions
How many devices does Cryocath Technologies, Inc. have in the registry?
The registry currently lists 6 devices for Cryocath Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cryocath Technologies, Inc.'s devices?
Among its 6 most recently registered devices, Cryocath Technologies, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Cryocath Technologies, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Cryocath Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cryocath Technologies, Inc.?
FDA recall records list 1 recall initiated by Cryocath Technologies, Inc., the most recent initiated on 2006-08-04. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cryocath Technologies, Inc. in the registry?
The most recently registered devices listed for Cryocath Technologies, Inc. include SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1, SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE, SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE and FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE.