SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

CRYOCATH TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Cryocath Technologies, Inc. with the FDA for Surgifrost 6cm, 7cm And 10 Cm Cryosurgical Devices Plus Frostbyte Clamp And Cryosurgical Console.

Pre-market Notification Details

• Device ID: K053436
• 510k Number: K053436
• Device Name: SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
• Classification: Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
• Applicant: CRYOCATH TECHNOLOGIES, INC. 204 CLINTON ROAD Brookline, MA 02445
• Contact: Fred Milder
• Correspondent: Fred Milder; CRYOCATH TECHNOLOGIES, INC. 204 CLINTON ROAD Brookline, MA 02445
• Product Code: OCL
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-12-09
• Decision Date: 2006-01-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994959454	K053436	000