TR BAND

Clamp, Vascular

TERUMO MEDICAL CORP.

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

Pre-market Notification Details

• Device ID: K070423
• 510k Number: K070423
• Device Name: TR BAND
• Classification: Clamp, Vascular
• Applicant: TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921
• Contact: Mark Unterreiner
• Correspondent: Mark Unterreiner; TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921
• Product Code: DXC
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-13
• Decision Date: 2007-03-28
• Summary: summary