REBOA Balloon Catheter

Catheter, Intravascular Occluding, Temporary

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Reboa Balloon Catheter.

Pre-market Notification Details

• Device ID: K160598
• 510k Number: K160598
• Device Name: REBOA Balloon Catheter
• Classification: Catheter, Intravascular Occluding, Temporary
• Applicant: NUMED, INC. 2880 MAIN STREET Hopkinton, NY 12965
• Contact: Nichelle Laflesh
• Correspondent: Nichelle Laflesh; NUMED, INC. 2880 MAIN STREET Hopkinton, NY 12965
• Product Code: MJN
• CFR Regulation Number: 870.4450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-02
• Decision Date: 2016-06-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10887714024549	K160598	000
10887714024730	K160598	000
10887714024747	K160598	000
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