CUFF-CATH

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

OHMEDA MEDICAL

The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Cuff-cath.

Pre-market Notification Details

• Device ID: K935090
• 510k Number: K935090
• Device Name: CUFF-CATH
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: OHMEDA MEDICAL COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109
• Contact: Jonathan S Kahan
• Correspondent: Jonathan S Kahan; OHMEDA MEDICAL COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-10-22
• Decision Date: 1994-10-14