IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY

Set, Administration, Intravascular

RYMED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Rymed Technologies, Inc. with the FDA for In Vision-plus Nano With Neutral Advantage Technology.

Pre-market Notification Details

• Device ID: K093489
• 510k Number: K093489
• Device Name: IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY
• Classification: Set, Administration, Intravascular
• Applicant: RYMED TECHNOLOGIES, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484
• Contact: Joseph Azary
• Correspondent: Joseph Azary; RYMED TECHNOLOGIES, INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2009-11-10
• Decision Date: 2010-07-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20817903010746	K093489	000
20817903010104	K093489	000
20817903010074	K093489	000
20817903010029	K093489	000
20817903010852	K093489	000
20817903010845	K093489	000
20817903010838	K093489	000
30817903010705	K093489	000
30817903010675	K093489	000