PROGREAT

Catheter, Continuous Flush

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Progreat.

Pre-market Notification Details

• Device ID: K033913
• 510k Number: K033913
• Device Name: PROGREAT
• Classification: Catheter, Continuous Flush
• Applicant: TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Contact: Mark Unterreiner
• Correspondent: Mark Unterreiner; TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921
• Product Code: KRA
• CFR Regulation Number: 870.1210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-17
• Decision Date: 2004-03-11
• Summary: summary