INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM

Set, Administration, Intravascular

RYMED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Rymed Technologies, Inc. with the FDA for Invision-plus Injection Port Connector System.

Pre-market Notification Details

• Device ID: K991653
• 510k Number: K991653
• Device Name: INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
• Classification: Set, Administration, Intravascular
• Applicant: RYMED TECHNOLOGIES, INC. 19526 EAST LAKE DR. Miami, FL 33015
• Contact: Al Weisenborn
• Correspondent: Al Weisenborn; RYMED TECHNOLOGIES, INC. 19526 EAST LAKE DR. Miami, FL 33015
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-05-13
• Decision Date: 1999-06-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10817903010862	K991653	000
20817903010081	K991653	000
20817903010098	K991653	000
20817903010142	K991653	000
20817903010159	K991653	000
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20817903010067	K991653	000
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10817903010879	K991653	000
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10817903010299	K991653	000
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20817903010791	K991653	000