DILATOR, VESSEL & INTRODUCER, SHEATH

Dilator, Vessel, For Percutaneous Catheterization

ARGON MEDICAL CORP.

The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Dilator, Vessel & Introducer, Sheath.

Pre-market Notification Details

• Device ID: K780126
• 510k Number: K780126
• Device Name: DILATOR, VESSEL & INTRODUCER, SHEATH
• Classification: Dilator, Vessel, For Percutaneous Catheterization
• Applicant: ARGON MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: DRE
• CFR Regulation Number: 870.1310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-01-24
• Decision Date: 1978-03-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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